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207 results on '"Bhattacharyya, H."'

8. Adjuvant sunitinib in patients with high-risk renal cell carcinoma: safety, therapy management, and patient-reported outcomes in the S-TRAC trial

Author

Staehler, M, Motzer, RJ, George, DJ, Pandha, HS, Donskov, F, Escudier, B, Pantuck, AJ, Patel, A, DeAnnuntis, L, Bhattacharyya, H, Ramaswamy, K, Zanotti, G, Lin, X, Lechuga, M, Serfass, L, Paty, J, and Ravaud, A

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Kidney Disease, Rare Diseases, Patient Safety, Clinical Research, Clinical Trials and Supportive Activities, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Antineoplastic Agents, Carcinoma, Renal Cell, Chemotherapy, Adjuvant, Disease Management, Double-Blind Method, Follow-Up Studies, Humans, International Agencies, Kidney Neoplasms, Neoplasm Recurrence, Local, Patient Reported Outcome Measures, Prognosis, Prospective Studies, Quality of Life, Sunitinib, Survival Rate, renal cell carcinoma, adjuvant sunitinib, cancer, patient-reported outcomes, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundAdjuvant sunitinib has significantly improved disease-free survival versus placebo in patients with renal cell carcinoma at high risk of recurrence post-nephrectomy (hazard ratio 0.76; 95% confidence interval, 0.59-0.98; two-sided P = 0.03). We report safety, therapy management, and patient-reported outcomes for patients receiving sunitinib and placebo in the S-TRAC trial.Patients and methodsPatients were stratified by the University of California, Los Angeles Integrated Staging System and Eastern Cooperative Oncology Group performance status score, and randomized (1 : 1) to receive sunitinib (50 mg/day) or placebo. Single dose reductions to 37.5 mg, dose delays, and dose interruptions were used to manage adverse events (AEs). Patients' health-related quality of life, including key symptoms typically associated with sunitinib, were evaluated with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).ResultsPatients maintained treatment for 9.5 (mean, SD 4.4) and 10.3 (mean, SD 3.7) months in the sunitinib and placebo arms, respectively. In the sunitinib arm, key AEs occurred ∼1 month (median) after start of treatment and resolved within ∼3.5 weeks (median). Many (40.6%) AEs leading to permanent discontinuation were grade 1/2, and most (87.2%) resolved or were resolving by 28 days after last treatment. Patients taking sunitinib showed a significantly lower EORTC QLQ-C30 overall health status score versus placebo, although this reduction was not clinically meaningful. Patients reported symptoms typically related to sunitinib treatment with diarrhea and loss of appetite showing clinically meaningful increases.ConclusionsIn S-TRAC, AEs were predictable, manageable, and reversible via dose interruptions, dose reductions, and/or standard supportive medical therapy. Patients on sunitinib did report increased symptoms and reduced HRQoL, but these changes were generally not clinically meaningful, apart from appetite loss and diarrhea, and were expected in the context of known sunitinib effects.Clinical trial registrationClinicalTrials.gov, NCT00375674.

Published
2018

9. Impact of palbociclib plus letrozole on patient-reported health-related quality of life: results from the PALOMA-2 trial

Author

Rugo, HS, Diéras, V, Gelmon, KA, Finn, RS, Slamon, DJ, Martin, M, Neven, P, Shparyk, Y, Mori, A, Lu, DR, Bhattacharyya, H, Bartlett, CHUANG, Iyer, S, Johnston, S, Ettl, J, and Harbeck, N

Subjects
Breast Cancer, Estrogen, Clinical Research, Aging, Clinical Trials and Supportive Activities, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Double-Blind Method, Female, Humans, Letrozole, Middle Aged, Piperazines, Placebos, Postmenopause, Pyridines, Quality of Life, palbociclib, letrozole, health-related quality of life, metastatic breast cancer, ER+/HER2-, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundPatient-reported outcomes are integral in benefit-risk assessments of new treatment regimens. The PALOMA-2 study provides the largest body of evidence for patient-reported health-related quality of life (QOL) for patients with metastatic breast cancer (MBC) receiving first-line endocrine-based therapy (palbociclib plus letrozole and letrozole alone).Patients and methodsTreatment-naïve postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) MBC were randomized 2 : 1 to palbociclib plus letrozole (n = 444) or placebo plus letrozole (n = 222). Patient-reported outcomes were assessed at baseline, day 1 of cycles 2 and 3, and day 1 of every other cycle from cycle 5 using the Functional Assessment of Cancer Therapy (FACT)-Breast and EuroQOL 5 dimensions (EQ-5D) questionnaires.ResultsAs of 26 February 2016, the median duration of follow-up was 23 months. Baseline scores were comparable between the two treatment arms. No significant between-arm differences were observed in change from baseline in FACT-Breast Total, FACT-General Total, or EQ-5D scores. Significantly greater improvement in pain scores was observed in the palbociclib plus letrozole arm (-0.256 versus -0.098; P = 0.0183). In both arms, deterioration of FACT-Breast Total score was significantly delayed in patients without progression versus those with progression and patients with partial or complete response versus those without. No significant difference was observed in FACT-Breast and EQ-5D index scores in patients with and without neutropenia.ConclusionsOverall, women with MBC receiving first-line endocrine therapy have a good QOL. The addition of palbociclib to letrozole maintains health-related QOL and improves pain scores in treatment-naïve postmenopausal patients with ER+/HER2- MBC compared with letrozole alone. Significantly greater delay in deterioration of health-related QOL was observed in patients without progression versus those who progressed and in patients with an objective response versus non-responders. ClinicalTrials.gov: NCT01740427 (https://clinicaltrials.gov/ct2/show/NCT01740427).

Published
2018

11. Quality of life with talazoparib versus physician’s choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial

Author

Ettl, J., Quek, R.G.W., Lee, K.-H., Rugo, H.S., Hurvitz, S., Gonçalves, A., Fehrenbacher, L., Yerushalmi, R., Mina, L.A., Martin, M., Roché, H., Im, Y.-H., Markova, D., Bhattacharyya, H., Hannah, A.L., Eiermann, W., Blum, J.L., and Litton, J.K.

Published
2018
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13. Patient-reported Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Harboring DNA Damage Response Alterations Treated with Talazoparib: Results from TALAPRO-1.

Author

Saad, F., Bono, J. de, Barthélémy, P., Dorff, T., Mehra, N., Scagliotti, G., Stirling, A., Machiels, J.P., Renard, V., Maruzzo, M., Higano, C.S., Gurney, H., Healy, C., Bhattacharyya, H., Arondekar, B., Niyazov, A., Fizazi, K., Saad, F., Bono, J. de, Barthélémy, P., Dorff, T., Mehra, N., Scagliotti, G., Stirling, A., Machiels, J.P., Renard, V., Maruzzo, M., Higano, C.S., Gurney, H., Healy, C., Bhattacharyya, H., Arondekar, B., Niyazov, A., and Fizazi, K.

Abstract

01 april 2023, Item does not contain fulltext, BACKGROUND: Talazoparib has shown antitumor activity with a manageable safety profile in men with metastatic castration-resistant prostate cancer (mCRPC) and DNA damage response (DDR)/homologous recombination repair (HRR) alterations. OBJECTIVE: To evaluate patient-reported health-related quality of life (HRQoL) and pain in patients who received talazoparib in the TALAPRO-1 study, with a special interest in patients harboring breast cancer susceptibility gene 1 or 2 (BRCA1/2) mutations. DESIGN, SETTING, AND PARTICIPANTS: TALAPRO-1 is a single-arm, phase 2 study in men with mCRPC DDR alterations either directly or indirectly involved in HRR, who previously received one to two taxane-based chemotherapy regimens for advanced prostate cancer and whose mCRPC progressed on one or more novel hormonal agents. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Men completed the European Quality-of-life Five-dimension Five-level scale (EQ-5D-5L), EQ-5D visual analog scale (VAS), and Brief Pain Inventory-Short Form at predefined time points during the study. The patient-reported outcome (PRO) population included men who completed a baseline and one or more postbaseline assessments before study end. Longitudinal mixed-effect models assuming an unstructured covariance matrix were used to estimate the mean (95% confidence interval [CI]) change from baseline for pain and general health status measurements among all patients and patients with BRCA1/2 mutations. RESULTS AND LIMITATIONS: In the 97 men in the PRO population treated with talazoparib (BRCA1/2, n = 56), the mean (95% CI) EQ-5D-5L Index improved (all patients, 0.05 [0.01, 0.08]; BRCA1/2 subset, 0.07 [0.03, 0.10]), as did the EQ-5D VAS scores (all patients, 5.42 [2.65, 8.18]; BRCA1/2 subset, 4.74 [1.07, 8.41]). Improvements in the estimated overall change from baseline (95% CI) in the mean worst pain were observed in all patients (-1.08 [-1.52, -0.65]) and the BRCA1/2 subset (-1.15 [-1.67, -0.62]). The probability of not havin

Published
2023

15. Patient (pt) reported pain and health-related quality of life (HRQoL) by genomic loss of heterozygosity (gLOH) status in men with metastatic castration-resistant prostate cancer (mCRPC) receiving talazoparib (TALA): TALAPRO-1

Author

Saad, F., primary, Stenzl, A., additional, Mehra, N., additional, Stirling, A., additional, Renard, V., additional, Machiels, J-P., additional, Dorff, T., additional, Maruzzo, M., additional, Nazari, J., additional, Bhattacharyya, H., additional, Healy, C., additional, Niyazov, A., additional, and Fizazi, K., additional

Published
2022
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16. 218P Patient-reported quality of life in patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2–) advanced breast cancer (ABC) treated with palbociclib (PAL) plus letrozole (LET): Results from PALOMA-4

Author

Hu, X., primary, Broughton, E., additional, Li, W., additional, Sun, T., additional, Shen, K., additional, Huang, C., additional, Sriuranpong, V., additional, Ngan, K.C.R., additional, Chia, Y.H., additional, Bhattacharyya, H., additional, Zhao, H., additional, Shen, J., additional, and Xu, B., additional

Published
2022
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18. Patient-reported pain by baseline pain status in men with metastatic Castration-Resistant Prostate Cancer (mCRPC) receiving Talazoparib (TALA): TALAPRO-1

Author

Stenzl, A., primary, Saad, F., additional, De Bono, J.S., additional, Higano, C.S., additional, Barthelemy, P., additional, Dorff, T., additional, Mehra, N., additional, Scagliotti, G.V., additional, Machiels, J-P., additional, Renard, V., additional, Maruzzo, M., additional, Gurney, H., additional, Stirling, A., additional, Cynthia, G.H., additional, Bhattacharyya, H., additional, Arondekar, B., additional, Niyazov, A., additional, and Fizazi, K., additional

Published
2021
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19. Health-Related Quality of Life (HRQoL) in men with metastatic Castration-Resistant Prostate Cancer (mCRPC) receiving Talazoparib (TALA): TALAPRO-1

Author

Stenzl, A., primary, Saad, F., additional, De Bono, J.S., additional, Higano, C.S., additional, Barthelemy, P., additional, Dorff, T., additional, Mehra, N., additional, Scagliotti, G.V., additional, Machiels, J-P., additional, Renard, V., additional, Maruzzo, M., additional, Gurney, H., additional, Stirling, A., additional, Healy, C.G., additional, Bhattacharyya, H., additional, Arondekar, B., additional, Niyazov, A., additional, and Fizazi, K., additional

Published
2021
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20. 581P Patient (pt) reported pain in men with metastatic castration-resistant prostate cancer (mCRPC) receiving talazoparib (TALA): TALAPRO-1

Author

Saad, F., primary, de Bono, J.S., additional, Barthelemy, P., additional, Dorff, T., additional, Mehra, N., additional, Scagliotti, G., additional, Stirling, A., additional, Machiels, J-P., additional, Renard, V., additional, Maruzzo, M., additional, Higano, C.S., additional, Gurney, H.P., additional, Healy, C., additional, Bhattacharyya, H., additional, Arondekar, B., additional, Niyazov, A., additional, and Fizazi, K., additional

Published
2021
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34. Impact of Palbociclib plus Letrozole on Health Related Quality of Life (HRQOL) compared with Letrozole alone in first-line Postmenopausal Patients with ER+ HER2- Metastatic Breast Cancer (MBC): Results from PALOMA-2 Bone Metastases Subgroup

Author

Ettl, J., primary, Harbeck, N., additional, Gelmon, K., additional, Mori, A., additional, Lu, D., additional, Bhattacharyya, H., additional, Iyer, S., additional, Finn, R.S., additional, and Rugo, H., additional

Published
2018
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35. Abstract P5-19-01: Impact of palbociclib plus letrozole on patient-reported general health status compared with letrozole alone in ER+/HER2- advanced/metastatic breast cancer

Author

Harbeck, N, primary, Dieras, V, additional, Finn, R, additional, Gelmon, KA, additional, Walshe, JM, additional, Shparyk, Y, additional, Mori, A, additional, Lui, DR, additional, Bhattacharyya, H, additional, Iyer, S, additional, Johnston, S, additional, and Rugo, HS, additional

Published
2018
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36. Adjuvant sunitinib (SU) in patients (pts) with high risk renal cell carcinoma (RCC): Safety and therapy management in S-TRAC trial

Author

Staehler, M., primary, Motzer, R.J., additional, George, D.J., additional, Pandha, H.S., additional, Donskov, F., additional, Escudier, B., additional, Kliment, J., additional, Pantuck, A.J., additional, Patel, A., additional, Deannuntis, L., additional, Bhattacharyya, H., additional, Lin, X., additional, Lechuga, M., additional, Serfass, L., additional, Patard, J-J., additional, and Ravaud, A., additional

Published
2017
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39. Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial

Author

Harbeck, N, Iyer, S, Turner, N, Cristofanilli, M, Ro, J, Andre, F, Loi, S, Verma, S, Iwata, H, Bhattacharyya, H, Theall, KP, Bartlett, CH, Loibl, S, Harbeck, N, Iyer, S, Turner, N, Cristofanilli, M, Ro, J, Andre, F, Loi, S, Verma, S, Iwata, H, Bhattacharyya, H, Theall, KP, Bartlett, CH, and Loibl, S

Abstract

BACKGROUND: In the PALOMA-3 study, palbociclib plus fulvestrant demonstrated improved progression-free survival compared with fulvestrant plus placebo in hormone receptor-positive, HER2- endocrine-resistant metastatic breast cancer (MBC). This analysis compared patient-reported outcomes (PROs) between the two treatment groups. PATIENTS AND METHODS: Patients were randomized 2 : 1 to receive palbociclib 125 mg/day orally for 3 weeks followed by 1 week off (n = 347) plus fulvestrant (500 mg i.m. per standard of care) or placebo plus fulvestrant (n = 174). PROs were assessed on day 1 of cycles 1-4 and of every other subsequent cycle starting with cycle 6 using the EORTC QLQ-C30 and its breast cancer module, QLQ-BR23. High scores (range 0-100) could indicate better functioning/quality of life (QoL) or worse symptom severity. Repeated-measures mixed-effect analyses were carried out to compare on-treatment overall scores and changes from baseline between treatment groups while controlling for baseline. Between-group comparisons of time to deterioration in global QoL and pain were made using an unstratified log-rank test and Cox proportional hazards model. RESULTS: Questionnaire completion rates were high at baseline and during treatment (from baseline to cycle 14, ≥95.8% in each group completed ≥1 question on the EORTC QLQ-C30). On treatment, estimated overall global QoL scores significantly favored the palbociclib plus fulvestrant group [66.1, 95% confidence interval (CI) 64.5-67.7 versus 63.0, 95% CI 60.6-65.3; P = 0.0313]. Significantly greater improvement from baseline in pain was also observed in this group (-3.3, 95% CI -5.1 to -1.5 versus 2.0, 95% CI -0.6 to 4.6; P = 0.0011). No significant differences were observed for other QLQ-BR23 functioning domains, breast or arm symptoms. Treatment with palbociclib plus fulvestrant significantly delayed deterioration in global QoL (P < 0.025) and pain (P < 0.001) compared with fulvestrant alone. CONCLUSION: Palbociclib plus f

Published
2016

40. Impact of palbociclib plus letrozole on health related quality of life (HRQOL) compared with letrozole alone in treatment naïve postmenopausal patients with ER+ HER2- metastatic breast cancer (MBC): results from PALOMA-2

Author

Rugo, H., primary, Dieras, V., additional, Gelmon, K.A., additional, Finn, R., additional, Slamon, D., additional, Miguel, M., additional, Neven, P., additional, Ettl, J., additional, Shparyk, Y., additional, Mori, A., additional, Lu, D.R., additional, Bhattacharyya, H., additional, Bartlett, C.H., additional, Iyer, S., additional, Johnston, S., additional, and Harbeck, N., additional

Published
2016
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41. Impact of palbociclib plus fulvestrant on patient reported general health status compared with fulvestrant alone in HR +, HER2- metastatic breast cancer

Author

Loibl, S., primary, Demichele, A., additional, Turner, N.M., additional, Cristofanilli, M., additional, Loi, S., additional, Verma, S., additional, Bhattacharyya, H., additional, Ke, Z., additional, Giorgetti, C., additional, Bartlett, C.H., additional, Iyer, S., additional, Colleoni, M., additional, Masuda, N., additional, Im, S.-A., additional, and Harbeck, N., additional

Published
2016
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43. Impact of palbociclib plus letrozole on pain severity and pain interference with daily activities in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer as first-line treatment

Author

Bell, T., primary, Crown, J.P., additional, Lang, I., additional, Bhattacharyya, H., additional, Zanotti, G., additional, Randolph, S., additional, Kim, S., additional, Huang, X., additional, Huang Bartlett, C., additional, Finn, R.S., additional, and Slamon, D., additional

Published
2016
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