Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer
| Autor: | Lorusso, D., Hilpert, F., Martin, A.G., Rau, J., Ottevanger, P., Greimel, E., Luck, H.J., Selle, F., Colombo, N., Kroep, J.R., Mirza, M.R., Berger, R., Pardo, B., Grischke, E.M., Berton-Rigaud, D., Martinez-Garcia, J., Vergote, I., Redondo, A., Cardona, A., Bastiere-Truchot, L., Bois, A. du, Kurzeder, C., Campo, J.M. del, Bover, I., Barretina-Ginesta, P., Ortega, E., Garcia, Y., Romero, I., Poveda, A., Herrero, A., Vidal, L., Rubio, M.J., Romeo, M., Mendiola, C., Arranz, J.A., Santaballa, A., Liano, A.G. de, Marme, F., Mahner, S., Canzler, U., Zorr, A., Gropp-Meier, M., Cayir, P., Schmalfeldt, B., Rautenberg, B., Meier, W., Belau, A., Gerber, B., Rein, D., Jackisch, C., Janni, W., Heubner, M., Pautier, P., Fabbro, M., Floquet, A., You, B., Favier, L., Joly, F., Weber, B., Hardy-Bessard, A.C., Gadducci, A., Tognon, G., DeCensi, A., Savarese, A., Pisano, C., Sonke, G., Reyners, A., Kristensen, G., Bjurberg, M., Rosenberg, P., Marth, C., PENELOPE Trial Investigators |
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| Přispěvatelé: | Lorusso, D, Hilpert, F, Gonzalez Martin, A, Rau, J, Ottevanger, P, Greimel, E, Luck, H, Selle, F, Colombo, N, Kroep, J, Mirza, M, Berger, R, Pardo, B, Grischke, E, Berton-Rigaud, D, Martinez-Garcia, J, Vergote, I, Redondo, A, Cardona, A, Bastiere-Truchot, L, Du Bois, A, Kurzeder, C, Del Campo, J, Bover, I, Barretina-Ginesta, P, Ortega, E, Garcia, Y, Romero, I, Poveda, A, Herrero, A, Vidal, L, Rubio, M, Romeo, M, Mendiola, C, Arranz, J, Santaballa, A, Gomez De Liano, A, Marme, F, Mahner, S, Canzler, U, Zorr, A, Gropp-Meier, M, Cayir, P, Schmalfeldt, B, Rautenberg, B, Meier, W, Belau, A, Gerber, B, Rein, D, Jackisch, C, Janni, W, Heubner, M, Pautier, P, Fabbro, M, Floquet, A, You, B, Favier, L, Joly, F, Weber, B, Hardy-Bessard, A, Gadducci, A, Tognon, G, Decensi, A, Savarese, A, Pisano, C, Sonke, G, Reyners, A, Kristensen, G, Bjurberg, M, Rosenberg, P, Marth, C, Targeted Gynaecologic Oncology (TARGON), Guided Treatment in Optimal Selected Cancer Patients (GUTS) |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Oncology
Receptor ErbB-3 medicine.medical_treatment Carcinoma Ovarian Epithelial Deoxycytidine 0302 clinical medicine Antineoplastic Agents Immunological Antineoplastic Combined Chemotherapy Protocols Clinical endpoint Aged 80 and over Ovarian Neoplasms 0303 health sciences education.field_of_study Obstetrics and Gynecology Middle Aged Progression-Free Survival ovarian cancer patient-reported outcomes 030220 oncology & carcinogenesis Female Pertuzumab medicine.drug Adult medicine.medical_specialty Paclitaxel overall survival Population Placebo patient-reported outcome Antibodies Monoclonal Humanized 03 medical and health sciences Double-Blind Method HER3 pertuzumab Internal medicine medicine Humans Patient Reported Outcome Measures RNA Messenger education 030304 developmental biology Aged Chemotherapy business.industry medicine.disease Gemcitabine Drug Resistance Neoplasm Topotecan business Ovarian cancer |
| Zdroj: | International Journal of Gynecological Cancer, 29(7), 1141-1147. BMJ PUBLISHING GROUP International Journal of Gynecological Cancer, 29(7), 1141-1147. LIPPINCOTT WILLIAMS & WILKINS |
| ISSN: | 1048-891X |
| Popis: | IntroductionThe PENELOPE trial evaluated pertuzumab added to chemotherapy for biomarker-selected platinum-resistant ovarian cancer. As previously reported, pertuzumab did not statistically significantly improve progression-free survival (primary end point: HR 0.74, 95% CI 0.50 to 1.11), although results in the paclitaxel and gemcitabine cohorts suggested activity. Here, we report final overall survival and patient-reported outcomes.Patients and methodsEligible patients had ovarian carcinoma that progressed during/within 6 months of completing ≥4 platinum cycles, low tumor human epidermal growth factor receptor 3 (HER3) mRNA expression, and ≤2 prior chemotherapy lines. Investigators selected single-agent topotecan, gemcitabine or weekly paclitaxel before patients were randomized to either placebo or pertuzumab (840→420 mg every 3 weeks), stratified by selected chemotherapy, prior anti-angiogenic therapy, and platinum-free interval. Final overall survival analysis (key secondary end point) was pre-specified after 129 deaths. Patient-reported outcomes (secondary end point) were assessed at baseline and every 9 weeks until disease progression.ResultsAt database lock (June 9, 2016), 130 (83%) of 156 randomized patients had died. Median follow-up was 27 months in the pertuzumab arm versus 26 months in the control arm. In the intent-to-treat population there was no overall survival difference between treatment arms (stratified HR 0.90, 95% CI 0.61 to 1.32; p=0.60). Results in subgroups defined by stratification factors indicated heterogeneity similar to previous progression-free survival results. Updated safety was similar to previously published results. Compliance with patient-reported outcomes questionnaire completion was >75% for all validated patient-reported outcomes measures. Pertuzumab demonstrated neither beneficial nor detrimental effects on patient-reported outcomes compared with placebo, except for increased diarrhea symptoms.DiscussionConsistent with the primary results, adding pertuzumab to chemotherapy for low tumor HER3 mRNA-expressing platinum-resistant ovarian cancer did not improve overall survival, but showed trends in some cohorts. Except for increased diarrhea symptoms, pertuzumab had no impact on patient-reported outcomes.ClinicalTrials.gov:ClinicalTrials.gov:NCT01684878. |
| Databáze: | OpenAIRE |
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