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1. Diagnosis and management of isolated serous tubal intraepithelial carcinoma: A qualitative focus group study

Author

Negri, S, Fisch, C, de Hullu, J, van Bommel, M, Simons, M, Bogaerts, J, Apperloo, M, Baiocchi, G, Bakker, J, Bart, J, van Beekhuizen, H, Bernardini, M, Boere, I, Bulten, J, Chen, L, Chrzan, A, Dorum, A, Ewing-Graham, P, Ferrero, A, Floter Radestad, A, Fruscio, R, Gaarenstroom, K, Garcia, C, Harter, P, Hoogstad-van Evert, J, de Iaco, P, Klooster, A, Kooreman, L, Jacobsen, M, Kruse, A, Kwon, J, Lawson, B, Lax, S, van Lonkhuijzen, L, Lu, K, Manchanda, R, Marchetti, C, Mccluggage, W, Mcnally, O, Mourits, M, Nicum, S, Norquist, B, Perrone, A, Piek, J, Polastro, L, Polee, M, Rabban, J, Reesink, N, de los Reyes Oliver Perez, M, Roes, E, Rychlik, A, Shih, I, Soong, T, Speiser, P, Stone, R, Tamussino, K, Tognon, G, Tuninetti, V, Valabrega, G, Vos, M, Welz, J, Zizioli, V, Hermens, R, Steenbeek, M, Negri S., Fisch C., de Hullu J. A., van Bommel M., Simons M., Bogaerts J., Apperloo M. J. A., Baiocchi G., Bakker J. L., Bart J., van Beekhuizen H. J., Bernardini M. Q., Boere I., Bulten J., Chen L. -M., Chrzan A., Dorum A., Ewing-Graham P. C., Ferrero A., Floter Radestad A., Fruscio R., Gaarenstroom K. N., Garcia C., Harter P., Hoogstad-van Evert J. S., de Iaco P., Klooster A., Kooreman L. F. S., Jacobsen M., Kruse A. -J., Kwon J. S., Lawson B. C., Lax S. F., van Lonkhuijzen L. R. C. W., Lu K. H., Manchanda R., Marchetti C., McCluggage W. G., McNally O. M., Mourits M. J. E., Nicum S., Norquist B. M., Perrone A. M., Piek J. M. J., Polastro L., Polee M. B., Rabban J. T., Reesink N., de los Reyes Oliver Perez M., Roes E. -M., Rychlik A., Shih I. -M., Soong T. R., Speiser P., Stone R. L., Tamussino K., Tognon G., Tuninetti V., Valabrega G., Vos M. C., Welz J., Zizioli V., Hermens R. P. M. G., Steenbeek M. P., Negri, S, Fisch, C, de Hullu, J, van Bommel, M, Simons, M, Bogaerts, J, Apperloo, M, Baiocchi, G, Bakker, J, Bart, J, van Beekhuizen, H, Bernardini, M, Boere, I, Bulten, J, Chen, L, Chrzan, A, Dorum, A, Ewing-Graham, P, Ferrero, A, Floter Radestad, A, Fruscio, R, Gaarenstroom, K, Garcia, C, Harter, P, Hoogstad-van Evert, J, de Iaco, P, Klooster, A, Kooreman, L, Jacobsen, M, Kruse, A, Kwon, J, Lawson, B, Lax, S, van Lonkhuijzen, L, Lu, K, Manchanda, R, Marchetti, C, Mccluggage, W, Mcnally, O, Mourits, M, Nicum, S, Norquist, B, Perrone, A, Piek, J, Polastro, L, Polee, M, Rabban, J, Reesink, N, de los Reyes Oliver Perez, M, Roes, E, Rychlik, A, Shih, I, Soong, T, Speiser, P, Stone, R, Tamussino, K, Tognon, G, Tuninetti, V, Valabrega, G, Vos, M, Welz, J, Zizioli, V, Hermens, R, Steenbeek, M, Negri S., Fisch C., de Hullu J. A., van Bommel M., Simons M., Bogaerts J., Apperloo M. J. A., Baiocchi G., Bakker J. L., Bart J., van Beekhuizen H. J., Bernardini M. Q., Boere I., Bulten J., Chen L. -M., Chrzan A., Dorum A., Ewing-Graham P. C., Ferrero A., Floter Radestad A., Fruscio R., Gaarenstroom K. N., Garcia C., Harter P., Hoogstad-van Evert J. S., de Iaco P., Klooster A., Kooreman L. F. S., Jacobsen M., Kruse A. -J., Kwon J. S., Lawson B. C., Lax S. F., van Lonkhuijzen L. R. C. W., Lu K. H., Manchanda R., Marchetti C., McCluggage W. G., McNally O. M., Mourits M. J. E., Nicum S., Norquist B. M., Perrone A. M., Piek J. M. J., Polastro L., Polee M. B., Rabban J. T., Reesink N., de los Reyes Oliver Perez M., Roes E. -M., Rychlik A., Shih I. -M., Soong T. R., Speiser P., Stone R. L., Tamussino K., Tognon G., Tuninetti V., Valabrega G., Vos M. C., Welz J., Zizioli V., Hermens R. P. M. G., and Steenbeek M. P.

Abstract

Objective: A Serous Tubal Intraepithelial Carcinoma (STIC) without concomitant invasive carcinoma is occasionally identified and associated with a high risk of subsequent peritoneal carcinomatosis. Management needs optimisation. This study explores professionals' opinions and clinical practices regarding the diagnosis, counselling, treatment and follow-up of isolated STIC to facilitate clinical decision making and optimise the direction of future research. A secondary aim is to assess international clinical guidelines. Design: Focus group study. Setting: Four online sessions. Population: International panel (n = 12 countries) of gynaecologists, gynaecologic oncologists, pathologists and medical oncologists (n = 49). Methods: A semi-structured interview guide was used. Two independent researchers analysed transcripts by open and axial coding. Results were organised in domains. Relevant (inter)national guidelines were screened for recommendations regarding isolated STIC. Main Outcome Measures: Professionals' opinions and clinical practices regarding isolated STIC management. Results: Regarding pathology, most professionals identified the SEE-FIM protocol as standard of care for high-risk patients, whereas variation exists in the histopathological examination of fallopian tubes in the general population. Confirmation of STIC diagnosis by a specialised pathologist was recommended. Regarding work-up and follow-up after STIC diagnosis, there was variety and discordance. Data on outcomes is limited. As for treatment, chemotherapy and PARP inhibitors were not recommended by most. Eleven guidelines provided limited recommendations. Conclusions: We identified recommendations and highlighted knowledge gaps in the diagnosis and management of isolated STIC. Moreover, recommendations in clinical guidelines are limited. There is an agreed need for international collaboration for the prospective registration of isolated STIC.

Published
2024

2. Survival associated with extent of radical hysterectomy in early-stage cervical cancer: a subanalysis of the Surveillance in Cervical CANcer (SCCAN) collaborative study

Author

Bizzarri, N, Querleu, D, Dostalek, L, van Lonkhuijzen, L, Giannarelli, D, Lopez, A, Salehi, S, Ayhan, A, Kim, S, Ortiz, D, Klat, J, Landoni, F, Pareja, R, Manchanda, R, Kostun, J, Ramirez, P, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Dos Reis, R, Pedone Anchora, L, Amaro, K, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Mom, C, Scambia, G, Falconer, H, Cibula, D, Bizzarri N., Querleu D., Dostalek L., van Lonkhuijzen L. R. C. W., Giannarelli D., Lopez A., Salehi S., Ayhan A., Kim S. H., Ortiz D. I., Klat J., Landoni F., Pareja R., Manchanda R., Kostun J., Ramirez P. T., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Dos Reis R., Pedone Anchora L., Amaro K., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Mom C. H., Scambia G., Falconer H., Cibula D., Bizzarri, N, Querleu, D, Dostalek, L, van Lonkhuijzen, L, Giannarelli, D, Lopez, A, Salehi, S, Ayhan, A, Kim, S, Ortiz, D, Klat, J, Landoni, F, Pareja, R, Manchanda, R, Kostun, J, Ramirez, P, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Dos Reis, R, Pedone Anchora, L, Amaro, K, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Mom, C, Scambia, G, Falconer, H, Cibula, D, Bizzarri N., Querleu D., Dostalek L., van Lonkhuijzen L. R. C. W., Giannarelli D., Lopez A., Salehi S., Ayhan A., Kim S. H., Ortiz D. I., Klat J., Landoni F., Pareja R., Manchanda R., Kostun J., Ramirez P. T., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Dos Reis R., Pedone Anchora L., Amaro K., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Mom C. H., Scambia G., Falconer H., and Cibula D.

Abstract

Background: International guidelines recommend tailoring the radicality of hysterectomy according to the known preoperative tumor characteristics in patients with early-stage cervical cancer. Objective: This study aimed to assess whether increased radicality had an effect on 5-year disease-free survival in patients with early-stage cervical cancer undergoing radical hysterectomy. The secondary aims were 5-year overall survival and pattern of recurrence. Study Design: This was an international, multicenter, retrospective study from the Surveillance in Cervical CANcer (SCCAN) collaborative cohort. Patients with the International Federation of Gynecology and Obstetrics 2009 stage IB1 and IIA1 who underwent open type B/C1/C2 radical hysterectomy according to Querleu-Morrow classification between January 2007 and December 2016, who did not undergo neoadjuvant chemotherapy and who had negative lymph nodes and free surgical margins at final histology, were included. Descriptive statistics and survival analyses were performed. Patients were stratified according to pathologic tumor diameter. Propensity score match analysis was performed to balance baseline characteristics in patients undergoing nerve-sparing and non–nerve-sparing radical hysterectomy. Results: A total of 1257 patients were included. Of note, 883 patients (70.2%) underwent nerve-sparing radical hysterectomy, and 374 patients (29.8%) underwent non–nerve-sparing radical hysterectomy. Baseline differences between the study groups were found for tumor stage and diameter (higher use of non–nerve-sparing radical hysterectomy for tumors >2 cm or with vaginal involvement; P<.0001). The use of adjuvant therapy in patients undergoing nerve-sparing and non–nerve-sparing radical hysterectomy was 27.3% vs 28.6%, respectively (P=.63). Five-year disease-free survival in patients undergoing nerve-sparing vs non–nerve-sparing radical hysterectomy was 90.1% (95% confidence interval, 87.9–92.2) vs 93.8% (95% confidence in

Published
2023

3. Stratification of lymph node metastases as macrometastases, micrometastases, or isolated tumor cells has no clinical implication in patients with cervical cancer: Subgroup analysis of the SCCAN project

Author

Dostalek, L, Benesova, K, Klat, J, Kim, S, Falconer, H, Kostun, J, dos Reis, R, Zapardiel, I, Landoni, F, Ortiz, D, van Lonkhuijzen, L, Lopez, A, Odetto, D, Borcinova, M, Jarkovsky, J, Salehi, S, Nemejcova, K, Bajsova, S, Park, K, Javurkova, V, Abu-Rustum, N, Dundr, P, Cibula, D, Dostalek L., Benesova K., Klat J., Kim S. H., Falconer H., Kostun J., dos Reis R., Zapardiel I., Landoni F., Ortiz D. I., van Lonkhuijzen L. R. C. W., Lopez A., Odetto D., Borcinova M., Jarkovsky J., Salehi S., Nemejcova K., Bajsova S., Park K. J., Javurkova V., Abu-Rustum N. R., Dundr P., Cibula D., Dostalek, L, Benesova, K, Klat, J, Kim, S, Falconer, H, Kostun, J, dos Reis, R, Zapardiel, I, Landoni, F, Ortiz, D, van Lonkhuijzen, L, Lopez, A, Odetto, D, Borcinova, M, Jarkovsky, J, Salehi, S, Nemejcova, K, Bajsova, S, Park, K, Javurkova, V, Abu-Rustum, N, Dundr, P, Cibula, D, Dostalek L., Benesova K., Klat J., Kim S. H., Falconer H., Kostun J., dos Reis R., Zapardiel I., Landoni F., Ortiz D. I., van Lonkhuijzen L. R. C. W., Lopez A., Odetto D., Borcinova M., Jarkovsky J., Salehi S., Nemejcova K., Bajsova S., Park K. J., Javurkova V., Abu-Rustum N. R., Dundr P., and Cibula D.

Abstract

Background: In cervical cancer, presence of lymph-node macrometastases (MAC) is a major prognostic factor and an indication for adjuvant treatment. However, since clinical impact of micrometastases (MIC) and isolated tumor-cells (ITC) remains controversial, we sought to identify a cut-off value for the metastasis size not associated with negative prognosis. Methods: We analyzed data from 967 cervical cancer patients (T1a1L1-T2b) registered in the SCCAN (Surveillance in Cervical CANcer) database, who underwent primary surgical treatment, including sentinel lymph-node (SLN) biopsy with pathological ultrastaging. The size of SLN metastasis was considered a continuous variable and multiple testing was performed for cut-off values of 0.01-1.0 mm. Disease-free survival (DFS) was compared between N0 and subgroups of N1 patients defined by cut-off ranges. Results: LN metastases were found in 172 (18%) patients, classified as MAC, MIC, and ITC in 79, 54, and 39 patients, respectively. DFS was shorter in patients with MAC (HR 2.20, P = 0.003) and MIC (HR 2.87, P < 0.001), while not differing between MAC/MIC (P = 0.484). DFS in the ITC subgroup was neither different from N0 (P = 0.127) nor from MIC/MAC subgroups (P = 0.449). Cut-off analysis revealed significantly shorter DFS compared to N0 in all subgroups with metastases ≥0.4 mm (HR 2.311, P = 0.04). The significance of metastases <0.4 mm could not be assessed due to limited statistical power (<80%). We did not identify any cut-off for the size of metastasis with significantly better prognosis than the rest of N1 group. Conclusions: In cervical cancer patients, the presence of LN metastases ≥0.4 mm was associated with a significant negative impact on DFS and no cut-off value for the size of metastasis with better prognosis than N1 was found. Traditional metastasis stratification based on size has no clinical implication.

Published
2023

4. Association of Hospital Surgical Volume With Survival in Early-Stage Cervical Cancer Treated With Radical Hysterectomy

Author

Bizzarri, N, Dostalek, L, Van Lonkhuijzen, L, Giannarelli, D, Lopez, A, Falconer, H, Querleu, D, Ayhan, A, Kim, S, Ortiz, D, Klat, J, Landoni, F, Rodriguez, J, Manchanda, R, Kostun, J, Ramirez, P, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Dos Reis, R, Pedone Anchora, L, Amaro, K, Salehi, S, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Mom, C, Scambia, G, Cibula, D, Bizzarri N., Dostalek L., Van Lonkhuijzen L. R. C. W., Giannarelli D., Lopez A., Falconer H., Querleu D., Ayhan A., Kim S. H., Ortiz D. I., Klat J., Landoni F., Rodriguez J., Manchanda R., Kostun J., Ramirez P. T., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Dos Reis R., Pedone Anchora L., Amaro K., Salehi S., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Mom C. H., Scambia G., Cibula D., Bizzarri, N, Dostalek, L, Van Lonkhuijzen, L, Giannarelli, D, Lopez, A, Falconer, H, Querleu, D, Ayhan, A, Kim, S, Ortiz, D, Klat, J, Landoni, F, Rodriguez, J, Manchanda, R, Kostun, J, Ramirez, P, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Dos Reis, R, Pedone Anchora, L, Amaro, K, Salehi, S, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Mom, C, Scambia, G, Cibula, D, Bizzarri N., Dostalek L., Van Lonkhuijzen L. R. C. W., Giannarelli D., Lopez A., Falconer H., Querleu D., Ayhan A., Kim S. H., Ortiz D. I., Klat J., Landoni F., Rodriguez J., Manchanda R., Kostun J., Ramirez P. T., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Dos Reis R., Pedone Anchora L., Amaro K., Salehi S., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Mom C. H., Scambia G., and Cibula D.

Abstract

OBJECTIVE: To evaluate the association of number of radical hysterectomies performed per year in each center with disease-free survival and overall survival. METHODS: We conducted an international, multicenter, retrospective study of patients previously included in the Surveillance in Cervical Cancer collaborative studies. Individuals with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IB1-IIA1 cervical cancer who underwent radical hysterectomy and had negative lymph nodes at final histology were included. Patients were treated at referral centers for gynecologic oncology according to updated national and international guidelines. Optimal cutoffs for surgical volume were identified using an unadjusted Cox proportional hazard model, with disease-free survival as the outcome and defined as the value that minimizes the P-value of the split in groups in terms of disease-free survival. Propensity score matching was used to create statistically similar cohorts at baseline. RESULTS: A total of 2,157 patients were initially included. The two most significant cutoffs for surgical volume were identified at seven and 17 surgical procedures, dividing the entire cohort into low-volume, middle-volume, and high-volume centers. After propensity score matching, 1,238 patients were analyzed - 619 (50.0%) in the high-volume group, 523 (42.2%) in the middle-volume group, and 96 (7.8%) in the low-volume group. Patients who underwent surgery in higher-volume institutions had progressively better 5-year disease-free survival than those who underwent surgery in lower-volume centers (92.3% vs 88.9% vs 83.8%, P=.029). No difference was noted in 5-year overall survival (95.9% vs 97.2% vs 95.2%, P=.70). Cox multivariable regression analysis showed that FIGO stage greater than IB1, presence of lymphovascular space invasion, grade greater than 1, tumor diameter greater than 20 mm, minimally invasive surgical approach, nonsquamous cell carcinoma histology, and lower-volum

Published
2023

8. SENTIX - SENTINEL LYMPH NODES IN PATIENTS WITH CERVICAL CANCER: SLN DETECTION AND THE FALSE NEGATIVE RATE OF SLN FROZEN SECTION (CEEGOG-CX01; ENGOT-CX2; NCT02494063): EP334

Author

Kocian, R, Köhler, C, Klat, J, Germanova, A, Plaikner, A, Bajsova, S, Marnitz, S, Ostojich, M, Zapardiel, I, Gil-Ibańez, B, Sehnal, B, Petiz, A, Pilka, R, Martin-Martinez, A, Presl, J, Buda, A, van Lonkhuijzen, L, Minar, L, Barahona, M, Wydra, D, Blecharz, P, Dundr, P, Dusek, L, and Cibula, D

Published
2019
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10. The annual recurrence risk model for tailored surveillance strategy in patients with cervical cancer

Author

Cibula, D, Dostalek, L, Jarkovsky, J, Mom, C, Lopez, A, Falconer, H, Fagotti, A, Ayhan, A, Kim, S, Isla Ortiz, D, Klat, J, Obermair, A, Landoni, F, Rodriguez, J, Manchanda, R, Kostun, J, dos Reis, R, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Benesova, K, Borcinova, M, Pari, D, Salehi, S, Bizzarri, N, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Slama, J, van Lonkhuijzen, L, Cibula D., Dostalek L., Jarkovsky J., Mom C. H., Lopez A., Falconer H., Fagotti A., Ayhan A., Kim S. H., Isla Ortiz D., Klat J., Obermair A., Landoni F., Rodriguez J., Manchanda R., Kostun J., dos Reis R., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Benesova K., Borcinova M., Pari D., Salehi S., Bizzarri N., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Slama J., van Lonkhuijzen L. R. C. W., Cibula, D, Dostalek, L, Jarkovsky, J, Mom, C, Lopez, A, Falconer, H, Fagotti, A, Ayhan, A, Kim, S, Isla Ortiz, D, Klat, J, Obermair, A, Landoni, F, Rodriguez, J, Manchanda, R, Kostun, J, dos Reis, R, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Benesova, K, Borcinova, M, Pari, D, Salehi, S, Bizzarri, N, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Slama, J, van Lonkhuijzen, L, Cibula D., Dostalek L., Jarkovsky J., Mom C. H., Lopez A., Falconer H., Fagotti A., Ayhan A., Kim S. H., Isla Ortiz D., Klat J., Obermair A., Landoni F., Rodriguez J., Manchanda R., Kostun J., dos Reis R., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Benesova K., Borcinova M., Pari D., Salehi S., Bizzarri N., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Slama J., and van Lonkhuijzen L. R. C. W.

Abstract

Purpose: Current guidelines for surveillance strategy in cervical cancer are rigid, recommending the same strategy for all survivors. The aim of this study was to develop a robust model allowing for individualised surveillance based on a patient's risk profile. Methods: Data of 4343 early-stage patients with cervical cancer treated between 2007 and 2016 were obtained from the international SCCAN (Surveillance in Cervical Cancer) consortium. The Cox proportional hazards model predicting disease-free survival (DFS) was developed and internally validated. The risk score, derived from regression coefficients of the model, stratified the cohort into significantly distinctive risk groups. On its basis, the annual recurrence risk model (ARRM) was calculated. Results: Five variables were included in the prognostic model: maximal pathologic tumour diameter; tumour histotype; grade; number of positive pelvic lymph nodes; and lymphovascular space invasion. Five risk groups significantly differing in prognosis were identified with a five-year DFS of 97.5%, 94.7%, 85.2% and 63.3% in increasing risk groups, whereas a two-year DFS in the highest risk group equalled 15.4%. Based on the ARRM, the annual recurrence risk in the lowest risk group was below 1% since the beginning of follow-up and declined below 1% at years three, four and >5 in the medium-risk groups. In the whole cohort, 26% of recurrences appeared at the first year of the follow-up, 48% by year two and 78% by year five. Conclusion: The ARRM represents a potent tool for tailoring the surveillance strategy in early-stage patients with cervical cancer based on the patient's risk status and respective annual recurrence risk. It can easily be used in routine clinical settings internationally.

Published
2021

11. Experiences, adherence and satisfaction with a combined exercise and dietary intervention for patients with ovarian cancer undergoing chemotherapy: A mixed-methods study

Author

Stelten, S, van Lonkhuijzen, L R C W, Hartman, Y A W, van Driel, W J, Winkels, R M, Kenter, G G, Buffart, L M, Hoedjes, M, Stelten, S, van Lonkhuijzen, L R C W, Hartman, Y A W, van Driel, W J, Winkels, R M, Kenter, G G, Buffart, L M, and Hoedjes, M

Abstract

Objective: This study examined experiences, adherence and satisfaction with a combined exercise and dietary intervention in patients with ovarian cancer and their healthcare professionals (HCPs) as part of the randomized PADOVA trial.Methods: A mixed-methods approach was used in 24 patients with ovarian cancer receiving first-line chemotherapy who were randomly allocated to a combined exercise and dietary intervention or usual care with counseling sessions post-treatment. Qualitative data on intervention experiences, adherence and satisfaction was collected using semi-structured interviews with patients and their HCPs (n = 18 physical therapists; n = 5 dietitians). Quantitative data on adherence and satisfaction was collected to provide context to qualitative data.Results: Exercise relative dose intensity ranged from 36 to 100% (median 72%) and patients attended 33-133% (median 100%) of the prescribed dietary counseling sessions. Patients appreciated guidance on exercise and nutrition and perceived benefits including improved physical fitness, quality of life, peer support and recovery after surgery and/or chemotherapy cycles. Both patients and HCPs were satisfied with the intervention and perceived that participation exceeded prior expectations. Median patient satisfaction score with the intervention was 8.5 out of 10. Suggestions for improving the intervention included further personalization of the number, content and scheduling of the sessions to preferences of patients and HCPs. Patients in the usual care group reported counseling sessions post-chemotherapy to be too little too late.Conclusions: Patients with ovarian cancer adhered well to the intervention. Numerous perceived benefits of the intervention were reported by patients and HCPs. Good adherence and positive experiences support successful implementation in clinical practice.

Published
2022

12. 12P Any size of lymph node metastasis should be considered N1 in patients with cervical cancer

Author

Cibula, D., primary, Benešová, K., additional, Klát, J., additional, Falconer, H., additional, Kim, S., additional, Van Lonkhuijzen, L., additional, Lopez, A., additional, Isla, D., additional, Landoni, F., additional, Kostun, J., additional, Dos Reis, R., additional, Odetto, D., additional, Zapardiel, I., additional, Borčinová, M., additional, Jarkovský, J., additional, Javůrková, V., additional, Salehi, S., additional, Abu-Rustum, N., additional, and Dostálek, L., additional

Published
2022
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13. 942 Survival after recurrence in early-stage cervical cancer patients

Author

Van Lonkhuijzen, L, primary, Dostalek, L, additional, Jarkovsky, J, additional, Lopez, A, additional, Falconer, H, additional, Scambia, G, additional, Ayhan, A, additional, Kim, S, additional, Isla Ortiz, D, additional, Klat, J, additional, Obermair, A, additional, Martino, GDI, additional, Pareja, R, additional, Manchanda, R, additional, Kostun, J, additional, Dos Reis, R, additional, Zapardiel, I, additional, Weinberger, V, additional, and Cibula, D, additional

Published
2021
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14. 960 The annual recurrence risk model for tailored surveillance strategy in cervical cancer patients

Author

Cibula, D, primary, Jarkovsky, J, additional, Van Lonkhuijzen, L, additional, Falconer, H, additional, Fagotti, A, additional, Ayhan, A, additional, Kim, S, additional, Isla Ortiz, D, additional, Klat, J, additional, Obermair, A, additional, Landoni, F, additional, Rodriguez, J, additional, Manchanda, R, additional, Kostun, J, additional, Dos Reis, R, additional, Meydanli, MM, additional, Odetto, D, additional, Laky, R, additional, Borčinová, M, additional, and Lopez, A, additional

Published
2021
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15. 966 SENTIX – accuracy of preoperative local staging in the sentix trial (CEEGOG-CX01; ENGOT-CX2; NCT02494063)

Author

Klat, J, primary, Kocian, R, additional, Kohler, C, additional, Jarkovsky, J, additional, Zapardiel, I, additional, Buda, A, additional, Van Lonkhuijzen, L, additional, Sehnal, B, additional, Arencibia Sanchez, O, additional, Torne, A, additional, Raspagliesi, F, additional, Presl, J, additional, Felsinger, M, additional, Pilka, R, additional, Ostojich, M, additional, Petiz, A, additional, Smrkolj, S, additional, Kridelka, F, additional, Dundr, P, additional, and Cibula, D, additional

Published
2021
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16. 179 Cancer worry amongBRCA1/2pathogenic variant carriers choosing surgery to prevent tubal/ovarian cancer

Author

Van Bommel, M, primary, Steenbeek, M, additional, Inthout, J, additional, Hermens, R, additional, Hoogerbrugge, N, additional, Van Doorn, H, additional, Mourits, M, additional, Van Beurden, M, additional, Zweemer, R, additional, Gaarenstroom, K, additional, Slangen, B, additional, Brood-van Zanten, M, additional, Vos, C, additional, Piek, J, additional, Van Lonkhuijzen, L, additional, Apperloo, M, additional, Coppus, S, additional, Prins, J, additional, Custers, J, additional, and De Hullu, J, additional

Published
2021
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17. 950 Sensitivity and false negativity of SLN frozen sectionhistological evaluation in the sentix trial (CEEGOG-CX01; ENGOT-CX2; NCT02494063)

Author

Kocian, R, primary, Kohler, C, additional, Bajsová, S, additional, Sebestova, S, additional, Zapardiel, I, additional, Martino, GDI, additional, Van Lonkhuijzen, L, additional, Sehnal, B, additional, Arencibia Sanchez, O, additional, Gil-Ibanez, B, additional, Martinelli, F, additional, Presl, J, additional, Minar, L, additional, Marek, R, additional, Kascak, P, additional, Havelka, P, additional, Michal, M, additional, Van Gorp, T, additional, Nemejcova, K, additional, and Cibula, D, additional

Published
2021
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18. SURVIVAL AFTER RECURRENCE IN EARLY-STAGE CERVICAL CANCER PATIENTS

Author

Van Lonkhuijzen, L., Dostalek, L., Jarkovsky, J., Lopez, A., Falconer, H., Scambia, G., Ayhan, A., Kim, S., Isla Ortiz, D., Klat, J., Obermair, A., Martino, Gdi, Pareja, R., Manchanda, R., Kostun, J., Dos Reis, R., Zapardiel, I., Weinberger, V., Cibula, D., Obstetrics and Gynaecology, and CCA - Cancer Treatment and Quality of Life

Published
2021

19. SENSITIVITY AND FALSE NEGATIVITY OF SLN FROZEN SECTIONHISTOLOGICAL EVALUATION IN THE SENTIX TRIAL (CEEGOG-CX01; ENGOT-CX2; NCT02494063)

Author

Kocian, R., Kohler, C., Bajsova, S., Sebestova, S., Zapardiel, I., Martino, G. D. I., Van Lonkhuijzen, L., Sehnal, B., Arencibia Sanchez, O., Gil-Ibanez, B., Martinelli, F., Presl, J., Minar, L., Marek, R., Kascak, P., Havelka, P., Michal, M., Van Gorp, T., Nemejcova, K., Cibula, D., Obstetrics and Gynaecology, and CCA - Cancer Treatment and Quality of Life

Published
2021

20. THE IMPACT OF MICROMETASTASES IN CERVICAL CANCER PATIENTS - A RETROSPECTIVE STUDY OF THE SCCAN (SURVEILLANCE IN CERVICAL CANCER) PROJECT

Author

Dostalek, L., Borcinova, M., Benesova, K., Klat, J., Falconer, H., Kim, S. H., Van Lonkhuijzen, L. R., Lopez, A., Isla Ortiz, D., Landoni, F., Kostun, J., Dos Reis, R., Odetto, D., Zapardiel, I., Jarkovsky, J., Javukova, V., Salehi, S., Abu-Rustum, N. R., Graf, P., Cibula, D., Obstetrics and Gynaecology, and CCA - Cancer Treatment and Quality of Life

Published
2021

22. The annual recurrence risk model for tailored surveillance strategy in patients with cervical cancer

Author

Cibula, D., Dostalek, L., Jarkovsky, J., Mom, C. H., Lopez, A., Falconer, H., Fagotti, Anna, Ayhan, A., Kim, S. H., Isla Ortiz, D., Klat, J., Obermair, A., Landoni, F., Rodriguez, J., Manchanda, R., Kostun, J., dos Reis, R., Meydanli, M. M., Odetto, D., Laky, R., Zapardiel, I., Weinberger, V., Benesova, K., Borcinova, M., Pari, D., Salehi, S., Bizzarri, N., Akilli, H., Abu-Rustum, N. R., Salcedo-Hernandez, R. A., Javurkova, V., Slama, J., van Lonkhuijzen, L. R. C. W., Fagotti A. (ORCID:0000-0001-5579-335X), Cibula, D., Dostalek, L., Jarkovsky, J., Mom, C. H., Lopez, A., Falconer, H., Fagotti, Anna, Ayhan, A., Kim, S. H., Isla Ortiz, D., Klat, J., Obermair, A., Landoni, F., Rodriguez, J., Manchanda, R., Kostun, J., dos Reis, R., Meydanli, M. M., Odetto, D., Laky, R., Zapardiel, I., Weinberger, V., Benesova, K., Borcinova, M., Pari, D., Salehi, S., Bizzarri, N., Akilli, H., Abu-Rustum, N. R., Salcedo-Hernandez, R. A., Javurkova, V., Slama, J., van Lonkhuijzen, L. R. C. W., and Fagotti A. (ORCID:0000-0001-5579-335X)

Abstract

Purpose: Current guidelines for surveillance strategy in cervical cancer are rigid, recommending the same strategy for all survivors. The aim of this study was to develop a robust model allowing for individualised surveillance based on a patient's risk profile. Methods: Data of 4343 early-stage patients with cervical cancer treated between 2007 and 2016 were obtained from the international SCCAN (Surveillance in Cervical Cancer) consortium. The Cox proportional hazards model predicting disease-free survival (DFS) was developed and internally validated. The risk score, derived from regression coefficients of the model, stratified the cohort into significantly distinctive risk groups. On its basis, the annual recurrence risk model (ARRM) was calculated. Results: Five variables were included in the prognostic model: maximal pathologic tumour diameter; tumour histotype; grade; number of positive pelvic lymph nodes; and lymphovascular space invasion. Five risk groups significantly differing in prognosis were identified with a five-year DFS of 97.5%, 94.7%, 85.2% and 63.3% in increasing risk groups, whereas a two-year DFS in the highest risk group equalled 15.4%. Based on the ARRM, the annual recurrence risk in the lowest risk group was below 1% since the beginning of follow-up and declined below 1% at years three, four and >5 in the medium-risk groups. In the whole cohort, 26% of recurrences appeared at the first year of the follow-up, 48% by year two and 78% by year five. Conclusion: The ARRM represents a potent tool for tailoring the surveillance strategy in early-stage patients with cervical cancer based on the patient's risk status and respective annual recurrence risk. It can easily be used in routine clinical settings internationally.

Published
2021

26. SENTIX - SENTINEL LYMPH NODES IN PATIENTS WITH CERVICAL CANCER: SLN DETECTION AND THE FALSE NEGATIVE RATE OF SLN FROZEN SECTION (CEEGOG-CX01; ENGOT-CX2; NCT02494063)

Author

Kocian, R., Koehler, C., Klat, J., Germanova, A., Plaikner, A., Bajsova, S., Marnitz, S., Ostojich, M., Zapardiel, I., Gil-Ibanez, B., Sehnal, B., Petiz, A., Pilka, R., Martin-Martinez, A., Presl, J., Buda, A., van Lonkhuijzen, L., Minar, L., Barahona, M., Wydra, D., Blecharz, P., Dundr, P., Dusek, L., Cibula, D., Gynecologic, Cent Eastern European, Gynaecological, Belgium Luxembourg, Obstetrics and Gynaecology, and CCA - Cancer Treatment and Quality of Life

Published
2019

27. BETTER QUALITY OF LIFE IN BRCA MUTATION CARRIERS AFTER SALPINGECTOMY WITH DELAYED OOPHORECTOMY COMPARED TO SALPINGO-OOPHORECTOMY; FIRST RESULTS OF THE DUTCH TUBA STUDY

Author

Steenbeek, M. P., Harmsen, M. G., Hoogerbrugge, N., Arts-de Jong, M., Maas, A. H. E. M., Prins, J. B., Bulten, J., Teerenstra, S., Piek, J. M. J., van Doorn, H. C., van Beurden, M., Mourits, M. J. E., Zweemer, R. P., Gaarenstroom, K. N., Slangen, B. F. M., Vos, M. C., van Lonkhuijzen, L. R. C. W., van Mello, N. M., Apperloo, M. J., Coppus, S. F. P. J., Massuger, L. F. A. G., Hermens, R. P. M. G., de Hullu, J. A., Obstetrics and Gynaecology, and CCA - Cancer Treatment and Quality of Life

Published
2019

28. THE CLINICAL POTENTIAL OF FOXL2 C.402C > G MUTATION DETECTION IN CIRCULATING TUMOUR DNA OF PATIENTS WITH GRANULOSA CELL TUMOURS

Author

Groeneweg, J. W., Roze, J. F., Monroe, G. M., Paijens, S. T., Nijman, H. W., van Meurs, H. S., van Lonkhuijzen, L. R. C. W., Piek, J. M. J., Lok, C. A. R., Jonges, G. N., Zweemer, R. P., Obstetrics and Gynaecology, CCA - Cancer Treatment and Quality of Life, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, Cardiology, Targeted Gynaecologic Oncology (TARGON), and Translational Immunology Groningen (TRIGR)

Published
2019

29. GENERATION OF ORGANOIDS FROM OVARIAN ADULT GRANULOSA CELL TUMOURS FOR INDIVIDUALIZED DRUG SCREENING

Author

Monroe, G., Roze, J., Stelloo, E., Stangl, C., Sereno, F., Groeneweg, J., Paijens, S., Nijman, H., van Meurs, H., van Lonkhuijzen, L., Piek, J., Lok, C., Jonges, G., Witteveen, P., Zweemer, R., Obstetrics and Gynaecology, CCA - Cancer Treatment and Quality of Life, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, Cardiology, and Radiology and Nuclear Medicine

Published
2019

31. P174 Generation of organoids from ovarian adult granulosa cell tumours for individualized drug screening

Author

Monroe, G, primary, Roze, J, additional, Stelloo, E, additional, Stangl, C, additional, Sereno, F, additional, Groeneweg, J, additional, Paijens, S, additional, Nijman, H, additional, van Meurs, H, additional, van Lonkhuijzen, L, additional, Piek, J, additional, Lok, C, additional, Jonges, G, additional, Witteveen, P, additional, and Zweemer, R, additional

Published
2019
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32. EP334 SENTIX – sentinel lymph nodes in patients with cervical cancer: SLN detection and the false negative rate of SLN frozen section (CEEGOG-CX01; ENGOT-CX2; NCT02494063)

Author

Kocian, R, primary, Köhler, C, additional, Klat, J, additional, Germanova, A, additional, Plaikner, A, additional, Bajsova, S, additional, Marnitz, S, additional, Ostojich, M, additional, Zapardiel, I, additional, Gil-Ibañez, B, additional, Sehnal, B, additional, Petiz, A, additional, Pilka, R, additional, Martin-Martinez, A, additional, Presl, J, additional, Buda, A, additional, van Lonkhuijzen, L, additional, Minar, L, additional, Barahona, M, additional, Wydra, D, additional, Blecharz, P, additional, Dundr, P, additional, Dusek, L, additional, and Cibula, D, additional

Published
2019
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33. Enhanced PeriOperative Care and Health protection programme for the prevention of surgical site infections after elective abdominal surgery (EPO2CH): statistical analysis plan of a randomised controlled multicentre superiority trial.

Author

de Jonge, S. W., Wolfhagen, N., Zwinderman, A. H., Hollmann, M. W., Boermeester, M. A., Dijkgraaf, M. G. W., for the EPO2CH study group, Boldingh, Q. J. J., Bom, W. J., Demirkiran, A., van Geffen, O. E., Hendriks, E. R., Hering, J. P., van der Hoeven, J. A. B., Kluyver, E. B., van der Leeuw, B. M. F., van Lonkhuijzen, L. R. C. W., Posthuma, L. M., Sonneveld, D. J. A., and Scheijmans, J. C. G.

Subjects
SURGICAL site infections, ELECTIVE surgery, PERIOPERATIVE care, ABDOMINAL surgery, HEALTH programs, INTRA-abdominal infections
Abstract

Background: Surgical site infections (SSI) are frequent complications after elective abdominal surgery. We designed the Enhanced PeriOperative Care and Health Protection programme (EPO2CH) care bundle, comprising of intraoperative high fractional inspired oxygen; intraoperative goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; glucose control and treatment of hyperglycaemia (> 10 mmol L- 1) in diabetics as well as non-diabetics; and wound irrigation before closure using an aqueous antiseptic. We hypothesise that EPO2CH added to standard care reduces the incidence of SSI compared to standard care alone for elective abdominal surgery.Methods: This trial is designed as an open label, pragmatic randomised controlled parallel-group multicentre superiority trial. The primary endpoint is the incidence of SSI, defined by the Centers for Disease Control and prevention, within 30 days after surgery. The incidence of SSI is assessed using the Dutch national complication register and medical chart review. Secondary endpoints include the SSI incidence within 90 days, incidence of anastomotic leakage at 30 and 90 days, the incidence of incisional hernia within 1 year, mortality within 1 year and 5 years, quality of life, health and disability, and cost-effectiveness. Primarily, an intention-to-treat analysis will be performed to estimate the relative risk using a log binomial model. If not feasible, a logistic regression will be used to estimate the odds ratio. A per-protocol analysis will also be performed. Furthermore, the attributive effect of the distinct interventions will be explored.Discussion: The results of the EPO2CH trial will determine if the EPO2CH bundle is effective to prevent SSI incidence for patients undergoing elective abdominal surgery. Details of the statistical analysis are described in this Statistical Analysis Plan (SAP).Trial Registration: Registration number: Dutch Trial Register Trial NL5572 . Registered on March 3, 2016. SAP version: V1.0, January 8, 2020. This SAP has been written based on study protocol V10. [ABSTRACT FROM AUTHOR]

Published
2021
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34. THE IMPACT OF GRADE IN ENDOMETRIOID ENDOMETRIAL CANCER INVADING CERVICAL STROMA AFTER HYSTERECTOMY AND BSO

Author

van Lonkhuijzen, L., Mom, C., Charles, R., Fons, G., Buist, M., Tjiong, M., Kenter, G., van der Velden, J., Obstetrics and Gynaecology, CCA - Cancer Treatment and Quality of Life, CCA - Cancer biology and immunology, Amsterdam Reproduction & Development (AR&D), Obstetrics and gynaecology, CCA - Treatment and quality of life, Amsterdam Reproduction & Development, CCA - Imaging and biomarkers, Physiology, and ACS - Heart failure & arrhythmias

Published
2017

37. Delay in safe motherhood

Author

van Lonkhuijzen, L., van den Berg, P.P., van Roosmalen, Jos, Scherpbier, A.J.J.A., Other Research, van den Berg, Maarten, and Research Institute Brain and Cognition (B&C)

Subjects
Malawi, Eclampsie, Kraamzorg, Zambia, Video, Vertraging, Sterfte, Kraamvrouwen, Kwaliteit, Scholing, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Proefschriften (vorm), GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries), Kwaliteitszorg, Nederland, gynaecologie en obstetrie
Abstract

Minder overlijden door zwangerschap: kloof tussen theorie en praktijk Wereldwijd overlijden jaarlijks zo’n 350.000 vrouwen als gevolg van zwangerschap en bevalling. De meeste van deze vrouwen wonen in arme landen. De belangrijkste oorzaken van de sterfte zijn onveilige abortus, infectie, hoge bloeddruk, hevig bloedverlies en een vastgelopen bevalling. Deze problemen zijn op papier eenvoudig te verhelpen. Maar de praktijk is weerbarstig, zo blijkt uit het promotieonderzoek van Luc van Lonkhuijzen In zijn proefschrift beschrijft hij onder meer een ‘maternity waiting home’, een plek bij het ziekenhuis waar vrouwen aan het eind van de zwangerschap kunnen verblijven zodat ze dichtbij zijn wanneer de bevalling begint. Dit kan een goede oplossing bieden. Toch blijken er vaak nog tal van obstakels te zijn, die vrouwen verhinderen van deze mogelijkheid gebruik te maken. In Malawi had het invoeren van een protocol en een checklist voor de behandeling van eclampsie een positief effect op de kwaliteit van zorg, zo blijkt verder uit het onderzoek. Training van zorgverleners in arme landen vergroot hun kennis wel, stelt van Lonkhuijzen vast, maar of dit ook leidt tot een verandering van gedrag en tot een verbetering van uitkomsten voor moeder en kind, is onduidelijk. In Nederland kan het invoeren van video-evaluatie op de verloskamers wellicht bijdragen aan de kwaliteit van de zorg. Zorgverleners en zwangeren blijken hier positief tegenover te staan. Luc van Lonkhuijzen (Rotterdam, 1970) studeerde geneeskunde te Leiden en werkte vier jaar in Afrika. Hij verrichtte zijn onderzoek aan de afdeling Obstetrie en Gynaecologie van het Universitair Medisch Centrum Groningen (UMCG) en binnen onderzoeksschool SHARE. Hij is thans werkzaam als fellow gynaecologische oncologie aan de universiteit van Toronto, Canada.

Published
2011

38. Implementing safe motherhood: A low-cost intervention to improve the management of eclampsia in a referral hospital in Malawi

Author

Drost, E., van Lonkhuijzen, L. R. C. W., Meguid, T., Lewis, D. Landis, Zeeman, G. G., and Obstetrics and Gynaecology

Subjects
Obstetric emergency, magnesium sulphate, quality of care, safe motherhood, Online training resources, Eclampsia, pregnancy, Millennium Development Goals, female genital diseases and pregnancy complications, reproductive and urinary physiology
Abstract

We evaluated the effect of so-called monitoring and treatment charts on the management of eclampsia in a referral hospital in Malawi. Baseline characteristics, clinical management, as well as overall maternal and perinatal outcome were compared by reviewing the medical files of two groups, before and after introduction of the charts in 2006. The use of the charts has resulted in improved monitoring of women with eclampsia and may have contributed to the reduction in the planned prelabour caesarean section rate from 87% to 33%, as more women underwent induction of labour after stabilisation (P = 0.020). Overall maternal and perinatal outcomes were similar.

Published
2010

43. Local health workers’ perceptions of substandard care in the management of obstetric hemorrhage in rural Malawi

Author

Beltman Jogchum Jan, van den Akker Thomas, Bwirire Dieudonné, Korevaar Anneke, Chidakwani Richard, van Lonkhuijzen Luc, and van Roosmalen Jos

Subjects
Gynecology and obstetrics, RG1-991
Abstract

Abstract Background To identify factors contributing to the high incidence of facility-based obstetric hemorrhage in Thyolo District, Malawi, according to local health workers. Methods Three focus group discussions among 29 health workers, including nurse-midwives and non-physician clinicians (‘medical assistants’ and ‘clinical officers’). Results Factors contributing to facility-based obstetric hemorrhage mentioned by participants were categorized into four major areas: (1) limited availability of basic supplies, (2) lack of human resources, (3) inadequate clinical skills of available health workers and (4) substandard referrals by traditional birth attendants and lack of timely self-referrals of patients. Conclusion Health workers in this district mentioned important community, system and provider related factors that need to be addressed in order to reduce the impact of obstetric hemorrhage.

Published
2013
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44. Stratification of lymph node metastases as macrometastases, micrometastases, or isolated tumor cells has no clinical implication in patients with cervical cancer: Subgroup analysis of the SCCAN project

Author

Dostálek, Lukáš, Benešová, Klára, Klát, Jaroslav, Kim, Sarah H., Falconer, Henrik, Kostun, Jan, dos Reis, Ricardo, Zapardiel, Ignacio, Landoni, Fabio, Ortiz, David Isla, van Lonkhuijzen, Luc R. C. W., Lopez, Aldo, Odetto, Diego, Borčinová, Martina, Jarkovsky, Jiri, Salehi, Sahar, Němejcová, Kristýna, Bajsová, Sylva, Park, Kay J., Javůrková, Veronika, Abu-Rustum, Nadeem R., Dundr, Pavel, Cibula, David, Dostalek, L, Benesova, K, Klat, J, Kim, S, Falconer, H, Kostun, J, dos Reis, R, Zapardiel, I, Landoni, F, Ortiz, D, van Lonkhuijzen, L, Lopez, A, Odetto, D, Borcinova, M, Jarkovsky, J, Salehi, S, Nemejcova, K, Bajsova, S, Park, K, Javurkova, V, Abu-Rustum, N, Dundr, P, Cibula, D, Obstetrics and Gynaecology, and CCA - Cancer Treatment and Quality of Life

Subjects
History, Low volume metastasis, Macrometastasi, Polymers and Plastics, Prognosi, Disease-free survival, Isolated tumor cells, Macrometastasis, Obstetrics and Gynecology, Isolated tumor cell, Classification, Prognosis, Industrial and Manufacturing Engineering, Low volume metastasi, Micrometastasis, Micrometastasi, Oncology, Cervical cancer, Histopathological ultrastaging, Business and International Management, Sentinel lymph node
Abstract

Background: In cervical cancer, presence of lymph-node macrometastases (MAC) is a major prognostic factor and an indication for adjuvant treatment. However, since clinical impact of micrometastases (MIC) and isolated tumor-cells (ITC) remains controversial, we sought to identify a cut-off value for the metastasis size not associated with negative prognosis. Methods: We analyzed data from 967 cervical cancer patients (T1a1L1-T2b) registered in the SCCAN (Surveillance in Cervical CANcer) database, who underwent primary surgical treatment, including sentinel lymph-node (SLN) biopsy with pathological ultrastaging. The size of SLN metastasis was considered a continuous variable and multiple testing was performed for cut-off values of 0.01-1.0 mm. Disease-free survival (DFS) was compared between N0 and subgroups of N1 patients defined by cut-off ranges. Results: LN metastases were found in 172 (18%) patients, classified as MAC, MIC, and ITC in 79, 54, and 39 patients, respectively. DFS was shorter in patients with MAC (HR 2.20, P = 0.003) and MIC (HR 2.87, P < 0.001), while not differing between MAC/MIC (P = 0.484). DFS in the ITC subgroup was neither different from N0 (P = 0.127) nor from MIC/MAC subgroups (P = 0.449). Cut-off analysis revealed significantly shorter DFS compared to N0 in all subgroups with metastases ≥0.4 mm (HR 2.311, P = 0.04). The significance of metastases

Published
2023
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45. Association of Hospital Surgical Volume With Survival in Early-Stage Cervical Cancer Treated With Radical Hysterectomy

Author

Bizzarri, Nicolò, Dostálek, Lukáš, van Lonkhuijzen, Luc R. C. W., Giannarelli, Diana, Lopez, Aldo, Falconer, Henrik, Querleu, Denis, Ayhan, Ali, Kim, Sarah H., Ortiz, David Isla, Klat, Jaroslav, Landoni, Fabio, Rodriguez, Juliana, Manchanda, Ranjit, Kosťun, Jan, Ramirez, Pedro T., Meydanli, Mehmet M., Odetto, Diego, Laky, Rene, Zapardiel, Ignacio, Weinberger, Vit, Dos Reis, Ricardo, Pedone Anchora, Luigi, Amaro, Karina, Salehi, Sahar, Akilli, Huseyin, Abu-Rustum, Nadeem R., Salcedo-Hernández, Rosa A., Javůrková, Veronika, Mom, Constantijne H., Scambia, Giovanni, Cibula, David, Obstetrics and Gynaecology, CCA - Cancer Treatment and Quality of Life, Bizzarri, N, Dostalek, L, Van Lonkhuijzen, L, Giannarelli, D, Lopez, A, Falconer, H, Querleu, D, Ayhan, A, Kim, S, Ortiz, D, Klat, J, Landoni, F, Rodriguez, J, Manchanda, R, Kostun, J, Ramirez, P, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Dos Reis, R, Pedone Anchora, L, Amaro, K, Salehi, S, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Mom, C, Scambia, G, Cibula, D, Obstetrics and gynaecology, CCA - Cancer Treatment and quality of life, CCA - Cancer biology and immunology, and Amsterdam Reproduction & Development (AR&D)

Subjects
Settore MED/40 - GINECOLOGIA E OSTETRICIA, Radical Hysterectomy, Obstetrics and Gynecology, Cervical Cancer, Hospital Surgical Volume, Surgery and Survival in Early-Stage Cervical Cancer
Abstract

OBJECTIVE: To evaluate the association of number of radical hysterectomies performed per year in each center with disease-free survival and overall survival. METHODS: We conducted an international, multicenter, retrospective study of patients previously included in the Surveillance in Cervical Cancer collaborative studies. Individuals with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IB1-IIA1 cervical cancer who underwent radical hysterectomy and had negative lymph nodes at final histology were included. Patients were treated at referral centers for gynecologic oncology according to updated national and international guidelines. Optimal cutoffs for surgical volume were identified using an unadjusted Cox proportional hazard model, with disease-free survival as the outcome and defined as the value that minimizes the P-value of the split in groups in terms of disease-free survival. Propensity score matching was used to create statistically similar cohorts at baseline. RESULTS: A total of 2,157 patients were initially included. The two most significant cutoffs for surgical volume were identified at seven and 17 surgical procedures, dividing the entire cohort into low-volume, middle-volume, and high-volume centers. After propensity score matching, 1,238 patients were analyzed - 619 (50.0%) in the high-volume group, 523 (42.2%) in the middle-volume group, and 96 (7.8%) in the low-volume group. Patients who underwent surgery in higher-volume institutions had progressively better 5-year disease-free survival than those who underwent surgery in lower-volume centers (92.3% vs 88.9% vs 83.8%, P=.029). No difference was noted in 5-year overall survival (95.9% vs 97.2% vs 95.2%, P=.70). Cox multivariable regression analysis showed that FIGO stage greater than IB1, presence of lymphovascular space invasion, grade greater than 1, tumor diameter greater than 20 mm, minimally invasive surgical approach, nonsquamous cell carcinoma histology, and lower-volume centers represented independent risk factors for recurrence. CONCLUSION: Surgical volume of centers represented an independent prognostic factor affecting disease-free survival. Increasing number of radical hysterectomies performed in each center every year was associated with improved disease-free survival.

Published
2023
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46. The annual recurrence risk model for tailored surveillance strategy in patients with cervical cancer

Author

Jaroslav Klat, Darwin Pari, Luc R.C.W. van Lonkhuijzen, Klára Benešová, Nicolò Bizzarri, Ignacio Zapardiel, Nadeem R. Abu-Rustum, Aldo Lopez, Jiří Sláma, Andreas Obermair, Fabio Landoni, Mehmet Mutlu Meydanli, Anna Fagotti, Diego Odetto, Veronika Javůrková, Sarah H. Kim, Vít Weinberger, Rosa A. Salcedo-Hernández, Jiri Jarkovsky, Henrik Falconer, Ali Ayhan, Jan Kosťun, David Cibula, L Dostalek, Constantijne H. Mom, Sahar Salehi, Juliana Rodriguez, Ranjit Manchanda, Martina Borčinová, Ricardo dos Reis, David Isla Ortiz, Rene Laky, Huseyin Akilli, Obstetrics and Gynaecology, CCA - Cancer Treatment and Quality of Life, Cibula, D, Dostalek, L, Jarkovsky, J, Mom, C, Lopez, A, Falconer, H, Fagotti, A, Ayhan, A, Kim, S, Isla Ortiz, D, Klat, J, Obermair, A, Landoni, F, Rodriguez, J, Manchanda, R, Kostun, J, dos Reis, R, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Benesova, K, Borcinova, M, Pari, D, Salehi, S, Bizzarri, N, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Slama, J, van Lonkhuijzen, L, Amsterdam Reproduction & Development (AR&D), CCA - Cancer Treatment and quality of life, and Obstetrics and gynaecology

Subjects
Cancer Research, medicine.medical_specialty, Article, Recurrence risk, 03 medical and health sciences, 0302 clinical medicine, Risk groups, Internal medicine, Medicine, In patient, Cervical cancer, 030219 obstetrics & reproductive medicine, Framingham Risk Score, Surveillance, business.industry, Proportional hazards model, medicine.disease, 3. Good health, Settore MED/40 - GINECOLOGIA E OSTETRICIA, Oncology, 030220 oncology & carcinogenesis, Annual recurrence risk, Cohort, Prognostic model, business
Abstract

Purpose Current guidelines for surveillance strategy in cervical cancer are rigid, recommending the same strategy for all survivors. The aim of this study was to develop a robust model allowing for individualised surveillance based on a patient's risk profile. Methods Data of 4343 early-stage patients with cervical cancer treated between 2007 and 2016 were obtained from the international SCCAN (Surveillance in Cervical Cancer) consortium. The Cox proportional hazards model predicting disease-free survival (DFS) was developed and internally validated. The risk score, derived from regression coefficients of the model, stratified the cohort into significantly distinctive risk groups. On its basis, the annual recurrence risk model (ARRM) was calculated. Results Five variables were included in the prognostic model: maximal pathologic tumour diameter; tumour histotype; grade; number of positive pelvic lymph nodes; and lymphovascular space invasion. Five risk groups significantly differing in prognosis were identified with a five-year DFS of 97.5%, 94.7%, 85.2% and 63.3% in increasing risk groups, whereas a two-year DFS in the highest risk group equalled 15.4%. Based on the ARRM, the annual recurrence risk in the lowest risk group was below 1% since the beginning of follow-up and declined below 1% at years three, four and >5 in the medium-risk groups. In the whole cohort, 26% of recurrences appeared at the first year of the follow-up, 48% by year two and 78% by year five. Conclusion The ARRM represents a potent tool for tailoring the surveillance strategy in early-stage patients with cervical cancer based on the patient's risk status and respective annual recurrence risk. It can easily be used in routine clinical settings internationally.

Published
2021
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47. Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy in High-Grade Epithelial Ovarian Cancer: A LANCE Randomized Clinical Trial.

Author

Rauh-Hain JA, Melamed A, Pareja R, May T, Sinno A, McNally L, Horowitz NS, De Iaco P, Michener CM, Van Lonkhuijzen L, Iniesta MD, Yuan Y, Ramirez PT, and Fagotti A

Subjects
Humans, Female, Middle Aged, Aged, Adult, Pilot Projects, Chemotherapy, Adjuvant methods, Robotic Surgical Procedures methods, Feasibility Studies, Laparotomy methods, Carcinoma, Ovarian Epithelial surgery, Carcinoma, Ovarian Epithelial drug therapy, Cytoreduction Surgical Procedures methods, Neoadjuvant Therapy methods, Laparoscopy methods, Ovarian Neoplasms surgery, Ovarian Neoplasms drug therapy, Ovarian Neoplasms pathology
Abstract

Importance: Despite the absence of high-quality evidence of its safety and effectiveness, minimally invasive surgery (MIS) is increasingly used to treat advanced epithelial ovarian cancer (EOC)., Objective: To assess the feasibility of conducting a full-scale randomized clinical trial (RCT) designed to compare the efficacy of MIS vs laparotomy in patients with advanced-stage EOC and a complete or partial response to neoadjuvant chemotherapy (NACT)., Design, Setting, and Participants: This lead-in pilot phase of LANCE (Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy), an international, open-label, noninferiority RCT, opened to enrollment in September 2020 and enrolled the 100th eligible patient in February 2023. It was conducted at 11 academic cancer centers in North America and Europe. Participants were adults with stage IIIC or IV epithelial ovarian, fallopian, or primary peritoneal carcinoma who had normal cancer antigen 125 levels and at least a partial radiologic response after 3 to 4 cycles of NACT. Patients were randomly assigned to receive either interval cytoreductive surgery performed using MIS or laparotomy. Data analysis was based on the evaluable population., Interventions: The MIS arm underwent laparoscopic or robotic surgery, vs laparotomy for the control arm. Resection of all visible tumor was attempted, and conversion from MIS to laparotomy was performed when necessary to attain complete resection., Main Outcomes and Measures: Trial feasibility was defined by 3 primary end points: patient accrual rate of at least 5.6 patients per month by the last month of the lead-in pilot phase, conversion from MIS to laparotomy in less than 25% of patients, and a difference in complete gross resection rates of fewer than 20 percentage points between study arms., Results: One hundred women (median [IQR] age, 63 [39-82] years) were included, of whom 49 were randomly assigned to MIS and 51 to laparotomy; 95 were evaluable for surgical outcomes. Most patients (34 [67%] in the laparotomy arm, and 33 [67%] in the MIS arm) had stage IIIC cancer. The monthly accrual rate reached 5.9 patients per month in the final month of the study. Six of 48 evaluable patients (12.5%; 95% CI, 4.7%-25.2%) assigned to MIS underwent conversion to laparotomy. Surgeons achieved a complete gross resection rate in 42 of 48 evaluable patients (88%) assigned to MIS and in 39 of 47 patients (83%) assigned to laparotomy (difference, 4.5 [95% CI, -9.7 to 18.8] percentage points)., Conclusions and Relevance: Results of this lead-in pilot study indicated the feasibility of the LANCE RCT to compare the oncological outcomes of MIS vs laparotomy., Trial Registration: ClinicalTrials.gov Identifier: NCT04575935.

Published
2024
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48. Body composition and peri- and postoperative complications in patients with gynaecological malignancies: A systematic review.

Author

Heus C, Stelten S, Kenter GG, Buffart LM, and van Lonkhuijzen LRCW

Subjects
Female, Humans, Gynecologic Surgical Procedures adverse effects, Gynecologic Surgical Procedures methods, Intraoperative Complications epidemiology, Intraoperative Complications etiology, Intraoperative Complications physiopathology, Body Composition physiology, Genital Neoplasms, Female surgery, Postoperative Complications epidemiology, Postoperative Complications etiology, Postoperative Complications physiopathology
Abstract

Background: In general abdominal surgery, the ratio of fat to muscle mass, or body composition measures, shows a stronger association with complications than body mass index. These studies include male and female patients. Women have a different body composition than men. Therefore, findings from general abdominal surgery cannot be extrapolated to women with cancer. The aim of this systematic review is to summarise the evidence on the association between body composition and peri- and postoperative complications in patients with gynaecological cancer., Methods: Pubmed, Embase and the Cochrane Central databases were searched in June 2023. Studies were eligible if they included patients undergoing surgery for gynaecological cancer and reported on the association between body composition (muscle or fat mass) and surgical complications. The quality of the studies was assessed using the Newcastle-Ottawa quality assessment scale. A best-evidence synthesis was used to summarise the level of evidence., Results: Fifteen studies were included that assessed muscle mass (n = 9) or fat mass (n = 6). We found strong evidence that there was no association between visceral fat and length of hospital stay. We found moderate evidence that a higher amount of good quality muscle was associated with a lower risk of postoperative complications. We found moderate evidence that there was no association between muscle or fat mass (i.e., muscle- or subcutaneous fat) and postoperative complications or fat mass and intraoperative complications. There was insufficient evidence for an association between visceral fat and intraoperative or postoperative complications, and for an association between muscle mass or -quality and length of hospital stay. There was high heterogeneity in the methods used to measure body composition, hampering meta-analyses., Conclusion: The association between body composition, particularly adipose tissue and muscle quality, and complications suggests that these measures may be of interest in determining postoperative risk in women undergoing surgery for gynaecological cancer., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Published
2024
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49. Sentinel lymph node pathological ultrastaging: Final outcome of the Sentix prospective international study in patients with early-stage cervical cancer.

Author

Kocian R, Kohler C, Bajsova S, Jarkovsky J, Zapardiel I, Di Martino G, van Lonkhuijzen L, Sehnal B, Sanchez OA, Gil-Ibanez B, Martinelli F, Presl J, Minar L, Pilka R, Kascak P, Havelka P, Michal M, van Gorp T, Nemejcova K, Dundr P, and Cibula D

Subjects
Humans, Female, Prospective Studies, Adult, Middle Aged, Aged, Uterine Cervical Neoplasms pathology, Uterine Cervical Neoplasms surgery, Neoplasm Staging, Sentinel Lymph Node Biopsy methods, Sentinel Lymph Node pathology, Sentinel Lymph Node surgery, Lymphatic Metastasis
Abstract

Objective: To report the outcome of SLN staging in the SENTIX international prospective trial of SLN biopsy in patients with cervical cancer with an intensive ultrastaging protocol and central quality control and to evaluate how the intensity of pathological assessment correlates with metastatic detection rate in SLNs., Methods: Eligible were patients with stages T1a1/LVSI+ to T1b2 (<4 cm, ≤2 cm for fertility sparing), common tumor types, no suspicious lymph nodes on imaging, and bilateral SLN detection. SLNs were examined intraoperatively and processed by an intensive protocol for ultrastaging (paraffin blocks sectioned completely in 150-μm intervals/levels). SLNs from each site were submitted for central quality control., Results: In the SENTIX SLN study, 647 out of 733 enrolled patients underwent SLN ultrastaging, identifying 12.5% (81/647) with node positive, N1 cases. Intraoperative detection revealed metastases in 56.8% (46/81) of these cases, categorized into macrometastases (83.7%), micrometastases (26.3%), and isolated tumor cells (9.1%). Ultrastaging identified additional metastatic involvement in 43.2% (35/81) of patients, with detailed sectioning revealing metastases (MAC/MIC) at first level in 20 cases (24.7%), at levels 2-4 in 9 cases (11.1%), and at level ≥5 in 6 cases (7.4%)., Conclusion: SLN ultrastaging detects additional 43% of N1 (MAC/MIC) in patients with negative LNs by imaging and intraoperative pathological assessment. The detection rate of positive SLN correlates with the intensity (number of levels) of ultrastaging. Examination of four levels from paraffin blocks, which detects >90% of patients with N1, is a reasonable compromise for an international standard for ultrastaging., Study Registration: NCT02494063 (ClinicalTrials.gov)., Competing Interests: Declaration of competing interest The authors report no conflict of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Published
2024
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50. Malnutrition is associated with poor survival in women receiving radiotherapy for cervical cancer.

Author

Laan J, van Lonkhuijzen L, Hinnen K, Pieters B, Dekker I, Stalpers L, and Westerveld H

Subjects
Humans, Female, Middle Aged, Retrospective Studies, Quality of Life, Radiotherapy, Adjuvant methods, Uterine Cervical Neoplasms epidemiology, Uterine Cervical Neoplasms radiotherapy, Uterine Cervical Neoplasms pathology, Malnutrition epidemiology, Malnutrition etiology
Abstract

Objective: Cancer patients are at risk of malnutrition, which is associated with poor oncological outcomes. The aim of this study was to assess the incidence of malnutrition before, during, and after radiotherapy in locally advanced cervical cancer patients. In addition, we evaluated the impact of malnutrition on survival, and whether and when malnourished patients were referred to a dietitian., Methods: This retrospective cohort study included cervical cancer patients who received primary or adjuvant radiotherapy with curative intent between January 2013 and January 2021. Patient and treatment characteristics, including longitudinal data on weight and dietary care, were retrieved from the electronic patient files. Malnutrition was defined by body mass index and weight loss according to the Global Leadership Initiative on Malnutrition (GLIM). Overall survival was estimated using the Kaplan-Meier method. Cox proportional hazard regression analysis was used to estimate hazard ratios for key prognostic factors., Results: A total of 294 patients were included. Median follow-up was 40 months (range 7-101 months). Malnutrition occurred in 44 patients (15%) at baseline, in 132 (45%) during radiotherapy, and in 63 (21%) during follow-up. Referral to a dietician occurred in 45% of the 138 patients who were malnourished before or during radiotherapy. Malnutrition was significantly associated with worse survival after adjusting for age, performance score, diabetes, histology, International Federation of Gynecology and Obstetrics (FIGO) stage, and nodal stage. The 3 year overall survival in patients with malnutrition was 77% (95% confidence interval (CI) 70% to 85%) and without malnutrition 89% (95% CI 83% to 95%); p=0.001). Independent significant risk factors for worse overall survival were: malnutrition, age ˃52 years, adenocarcinoma, FIGO stage III/IV, and N1 disease., Conclusion: Malnutrition was common in cervical cancer patients treated with radiotherapy and was associated with a shorter overall survival. Further studies are needed to evaluate the effectiveness of better monitoring of malnutrition and faster and better dietary intervention on survival and quality of life., Competing Interests: Competing interests: BP: grant ELEKTA (payment to the institution) and payment by BD (to the institution)., (© IGCS and ESGO 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2024
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