Int J Oncol. 2013 May;42(5):1778-85. doi: 10.3892/ijo.2013.1869.

A randomized phase II non-comparative study of pemetrexedcarboplatin and gemcitabinevinorelbine in anthracycline- and taxane-pretreated advanced breast cancer patients

DINO AMADORI1, EVA CARRASCO2, SIEGFRIED ROESEL3, ROBERTO LABIANCA4, BEATRICE UZIELY5,VICTORIA SOLDATENKOVA6, VALERIE MOREAU7, DURISALA DESAIAH8,THOMAS BAUKNECHT6and MIGUEL MARTIN9

1Romagnolo Scientific Institute for the Study and Treatment of Cancer, Meldola, Italy; 2Spanish Breast Cancer Research Group (GEICAM), Madrid, Spain; 3Gütersloh Oncology Practice, Gütersloh, Germany; 4Riuniti Hospital, Bergamo, Italy; 5Hadassah-Hebrew University Medical Center, Jerusalem, Israel; 6Lilly Deutschland, Bad Homburg, Germany; 7Lilly France, Paris, France; 8Eli Lilly and Company, Indianapolis, IN, USA; 9Gregorio Marañón University Hospital Research Institute, Complutense University, Madrid, Spain

 

Abstract

Pemetrexed-carboplatin and gemcitabine‑vinorelbine combination therapies were efficacious in phase II and phase III studies as first-line breast cancer treatment. Thus, Arm A and Arm B combinations were investigated in patients pretreated with anthracycline and taxanes. Women with advanced breast cancer, with ≥1 measurable lesion per RECIST, were stratified by line of treatment (1st, 2nd), visceral disease (yes/no), ECOG PS (0-1 vs. 2) and randomized 1:1 to Arm A (pemetrexed 600 mg/m2, D1 i.v. q21; carboplatin, AUC 5, D1 i.v. q21) or Arm B (gemcitabine 1,200 mg/m2 D1, D8 i.v. q21; vinorelbine 30 mg/m2 D1, D8 i.v. q21). Treatment continued until progression. The primary endpoint was objective response rate (RR). Secondary endpoints were duration of response (DoR), time-to-response (TTR), time-to-progressive disease (TTPD), time-to-treatment failure (TTTF) and safety. A two-stage design was employed independently for each arm. Of 135 randomized patients, 125 (Arm A, n=64; Arm B, n=61) qualified for tumor-response analysis. The mean (standard deviation) number of cycles administered was 6.3 (4.13) in Arm A and 6.2 (4.39) in Arm B. Efficacy in Arm A and Arm B were: RR (95% CI), 26.6 (16.3-39.1) and 29.5 (18.5-42.6); time-to-events (months), DoR 7.7 and 7.5; TTPD, 5.1 and 5.6; TTR, 1.8 and 1.8; TTTF, 4.8 and 5.1; respectively. Most common grade 3/4 adverse events possibly related to study-drug were neutropenia, thrombocytopenia, anemia and leucopenia in Arm A and neutropenia, leucopenia and fatigue in Arm B. In this study, both combinations showed moderate activity as predefined RR was not reached and were well tolerated.

PMID: 23546172

Multiselect Ultimate Query Plugin by InoPlugs Web Design Vienna | Webdesign Wien and Juwelier SchönmannMultiselect Ultimate Query Plugin by InoPlugs Web Design Vienna | Webdesign Wien and Juwelier Schönmann