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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

6. 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

7. 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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8. 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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9. 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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10. 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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11. 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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12. 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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13. 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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14. Improving referral rates for smoking cessation: A multifaceted intervention aimed at radiation oncologists.

Author

Bronsema I, van Lonkhuijzen L, Scholten P, Laan J, Westerveld H, and Stalpers L

Abstract

Objective: Continuation of smoking after a cancer diagnosis increases the burdensome side effects from cancer treatment, and decreases the chances of cure. Smoking cessation may improve oncological outcomes in cancer patients. This study aims to evaluate if radiation oncologists can be motivated by a smoking cessation awareness intervention to discuss smoking status more frequently and increase the referral rate for smoking cessation-support.Study design and Setting:A multifaceted approach was used to improve awareness: First, current practice was evaluated by a retrospective chart review of 282 patients referred for radiotherapy to ascertain smoking status, discussion of smoking cessation support and referral rates. Secondly, radiation oncologists were interviewed about their motives and barriers to discuss smoking status and smoking cessation support. The results were fed back in a teaching lecture to the doctors involved. Finally, the effect of this smoking cessation awareness intervention was prospectively evaluated in 100 patients., Results: After the smoking cessation awareness intervention, smoking cessation was more frequently discussed compared to baseline (77% (10/13)) and 39.5% (17/43) respectively. The referral rate for smoking cessation increased from 2.3% (1/43) to 69.2% (9/13)., Conclusion: Without an active smoking prevention awareness policy, referral for smoking cessation support for cancer patients by radiation oncologists is low. A relatively short and simple smoking awareness intervention for radiation oncologist may result in a more frequent discussion with patients about smoking cessation and an even larger increase in referrals for smoking cessation support., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Author(s).)

Published
2023
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15. Clinical outcomes of pelvic exenteration for gynecologic malignancies.

Author

Moolenaar LR, van Rangelrooij LE, van Poelgeest MIE, van Beurden M, van Driel WJ, van Lonkhuijzen LRCW, Mom CH, and Zaal A

Subjects
Humans, Female, Retrospective Studies, Margins of Excision, Neoplasm Recurrence, Local pathology, Genital Neoplasms, Female, Pelvic Exenteration adverse effects, Pelvic Exenteration methods, Uterine Cervical Neoplasms pathology
Abstract

Objectives: The aim of this study was to analyze morbidity and survival after pelvic exenteration for gynecologic malignancies and evaluate prognostic factors influencing postoperative outcome., Methods: We retrospectively reviewed all patients who underwent a pelvic exenteration at the departments of gynecologic oncology of three tertiary care centers in the Netherlands, the Leiden University Medical Centre, the Amsterdam University Medical Centre, and the Netherlands Cancer Institute, during a 20-year period. We determined postoperative morbidity, 2- and 5-year overall survival (OS) and 2- and 5-year progression free survival (PFS), and investigated parameters influencing these outcomes., Results: A total of 90 patients were included. The most common primary tumor was cervical cancer (n = 39, 43.3%). We observed at least one complication in 83 patients (92%). Major complications were seen in 55 patients (61%). Irradiated patients had a higher risk of developing a major complication. Sixty-two (68.9%) required ≥1 readmission. Re-operation was required in 40 patients (44.4%). Median OS was 25 months and median PFS was 14 months. The 2-year OS rate was 51.1% and the 2-year PFS rate was 41.5%. Tumor size, resection margins and pelvic sidewall involvement had a negative impact on OS (HR = 2.159, HR = 2.376, and HR = 1.200, respectively). Positive resection margins and pelvic sidewall involvement resulted in decreased PFS (HR = 2.567 and HR = 3.969, respectively)., Conclusion: Postoperative complications after pelvic exenteration for gynecologic malignancies are common, especially in irradiated patients. In this study, a 2-year OS rate of 51.1% was observed. Positive resections margins, tumor size, and pelvic sidewall involvement were related to poor survival outcomes. Adequate selection of patients who will benefit from pelvic exenteration is important., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare and there is no financial interest to report. We certify that the submission is original work and is not under review at any other publication., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Published
2023
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16. Role of adjuvant therapy in intermediate-risk cervical cancer patients - Subanalyses of the SCCAN study.

Author

Cibula D, Akilli H, Jarkovsky J, van Lonkhuijzen L, Scambia G, Meydanli MM, Ortiz DI, Falconer H, Abu-Rustum NR, Odetto D, Klát J, Dos Reis R, Zapardiel I, Di Martino G, Presl J, Laky R, López A, Weinberger V, Obermair A, Pareja R, Poncová R, Mom C, Bizzarri N, Borčinová M, Aslan K, Salcedo Hernandez RA, Fons G, Benešová K, Dostálek L, and Ayhan A

Subjects
Female, Humans, Neoplasm Staging, Hysterectomy, Combined Modality Therapy, Prognosis, Radiotherapy, Adjuvant, Retrospective Studies, Uterine Cervical Neoplasms pathology
Abstract

Objective: The "intermediate-risk" (IR) group of early-stage cervical cancer patients is characterized by negative pelvic lymph nodes and a combination of tumor-related prognostic risk factors such as tumor size ≥2 cm, lymphovascular space invasion (LVSI), and deep stromal invasion. However, the role of adjuvant treatment in these patients remains controversial. We investigated whether adjuvant (chemo)radiation is associated with a survival benefit after radical surgery in patients with IR cervical cancer., Methods: We analyzed data from patients with IR cervical cancer (tumor size 2-4 cm plus LVSI OR tumor size >4 cm; N0; no parametrial invasion; clear surgical margins) who underwent primary curative-intent surgery between 2007 and 2016 and were retrospectively registered in the international multicenter Surveillance in Cervical CANcer (SCCAN) study., Results: Of 692 analyzed patients, 274 (39.6%) received no adjuvant treatment (AT-) and 418 (60.4%) received radiotherapy or chemoradiotherapy (AT+). The 5-year disease-free survival (83.2% and 80.3%; P DFS = 0.365) and overall survival (88.7% and 89.0%; P OS = 0.281) were not significantly different between the AT- and AT+ groups, respectively. Adjuvant (chemo)radiotherapy was not associated with a survival benefit after adjusting for confounding factors by case-control propensity score matching or in subgroup analyses of patients with tumor size ≥4 cm and <4 cm. In univariable analysis, adjuvant (chemo)radiotherapy was not identified as a prognostic factor in any of the subgroups (full cohort: P DFS = 0.365; P OS = 0.282)., Conclusion: Among patients with IR early-stage cervical cancer, radical surgery alone achieved equal disease-free and overall survival rates to those achieved by combining radical surgery with adjuvant (chemo)radiotherapy., Competing Interests: Declaration of Competing Interest The authors declared no conflicts of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Published
2023
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17. 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 LRCW, Hartman YAW, van Driel WJ, Winkels RM, Kenter GG, Buffart LM, and Hoedjes M

Subjects
Carcinoma, Ovarian Epithelial drug therapy, Female, Humans, Patient Satisfaction, Personal Satisfaction, Ovarian Neoplasms drug therapy, Quality of Life
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., Competing Interests: Declaration of Competing Interest The authors have no relevant financial or non-financial interests to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Published
2022
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