Objective In platinum-resistant ovarian cancer, adding pertuzumab to gemcitabine improved progression-free survival in the subgroup with low tumor HER3 messenger RNA expression. The 2-part PENELOPE trial (NCT01684878) is prospectively investigating pertuzumab plus chemotherapy in this population. Patients and Methods Part 1 evaluated pertuzumab plus either topotecan or paclitaxel. Patients with platinum-refractory or platinum-resistant recurrent ovarian, primary peritoneal, or fallopian tube cancer and low HER3 messenger RNA expression (concentration ratio ≤2.81 by central quantitative reverse transcriptase-polymerase chain reaction testing on Cobas z480) received intravenous pertuzumab (840 mg loading dose then 420 mg every 3 weeks) with the investigator's choice of topotecan (1.25 mg/m2 days 1-5 every 3 weeks) or weekly paclitaxel (80 mg/m2) until disease progression or unacceptable toxicity. The primary objective was to assess safety and tolerability. Results Fifty patients were treated in part 1 (22 topotecan; 28 paclitaxel). In both cohorts, disease progression was the most common primary reason for discontinuing pertuzumab, and the most common all-grade adverse events (AEs) were fatigue/asthenia, anemia, and diarrhea. The most common grade ≥3 AEs were anemia (36%), neutropenia (27%), and fatigue/asthenia (18%) for topotecan, and peripheral sensory neuropathy (14%) and anemia (11%) for paclitaxel. Two patients receiving paclitaxel-pertuzumab died from AEs (abdominal infection; unexplained death). Median progression-free survival was 4.1 months (95% confidence interval, 1.9-6.1) with topotecan-pertuzumab and 4.2 months (95% confidence interval, 3.5-6.0) with paclitaxel-pertuzumab. Conclusions Based on part 1 tolerability, the Independent Data Monitoring Committee had no objection to PENELOPE proceeding to part 2, a double-blind randomized comparison of chemotherapy (topotecan, paclitaxel, or gemcitabine) plus pertuzumab or placebo.
González-Martín, A., Pautier, P., Mahner, S., Rau, J., Colombo, N., Ottevanger, P., et al. (2016). Pertuzumab Plus Chemotherapy for Platinum-Resistant Ovarian Cancer: Safety Run-in Results of the PENELOPE Trial. INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER, 26(5), 898-905 [10.1097/IGC.0000000000000695].
|Citazione:||González-Martín, A., Pautier, P., Mahner, S., Rau, J., Colombo, N., Ottevanger, P., et al. (2016). Pertuzumab Plus Chemotherapy for Platinum-Resistant Ovarian Cancer: Safety Run-in Results of the PENELOPE Trial. INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER, 26(5), 898-905 [10.1097/IGC.0000000000000695].|
|Tipo:||Articolo in rivista - Articolo scientifico|
|Carattere della pubblicazione:||Scientifica|
|Presenza di un coautore afferente ad Istituzioni straniere:||Si|
|Titolo:||Pertuzumab Plus Chemotherapy for Platinum-Resistant Ovarian Cancer: Safety Run-in Results of the PENELOPE Trial|
|Autori:||González-Martín, A; Pautier, P; Mahner, S; Rau, J; Colombo, N; Ottevanger, P; Del Campo, J; Selle, F; du Bois, A; Gadducci, A; García, Y; Berton-Rigaud, D; Marmé, F; Ortega, E; Martin, N; Bastiere-Truchot, L; Kiermaier, A; Kurzeder, C|
|Data di pubblicazione:||2016|
|Rivista:||INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1097/IGC.0000000000000695|
|Appare nelle tipologie:||01 - Articolo su rivista|