371P - A multicenter phase II trial of nab-paclitaxel in combination with capecitabine in patients (pts) with HER-2 negative and triple negative advanced...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Breast Cancer
Biological Therapy
Presenter Mariangela Ciccarese
Citation Annals of Oncology (2014) 25 (suppl_4): iv116-iv136. 10.1093/annonc/mdu329
Authors M. Ciccarese1, L. Orlando2, P. Fedele3, P. Schiavone2, E. Maiello4, P. Cilenti5, M. Aieta6, G. Bozza6, M.R.C. Forcignanò1, A. Febbraro7, R. Bordonaro8, S. Romito9, A. Rinaldi10, N. Borsellino11, F. Riccardi12, S. Pisconti13, V. Lorusso14, G. Colucci15, S. Cinieri16
  • 1Oncology Dept., Ospedale Vito Fazzi, 73100 - Lecce/IT
  • 2Ospedale Perrino, Oncologia Brindisi, 72100 - Brindisi/IT
  • 3Oncology & Breast Unit, Antonio Perrino Hospital, 72100 - Brindisi/IT
  • 4Oncology, Casa Sollievo della Sofferenza, S. Giovanni Rotondo/IT
  • 5Oncology Dept., Casa Sollievo della Sofferenza, S. Giovanni Rotondo/IT
  • 6Medical Oncology, Department of Medical Oncology, National Institute of Cancer, Rionero in Vulture (PZ)., 70122 - Rionero (PZ)/IT
  • 7Oncology, Ospedale Fatebenefratelli Benevento, Benevento/IT
  • 8Oncology, “Garibaldi Nesima Superiore” Hospital, Catania/IT
  • 9Onco-ematologia Universitaria, Ospedale Riuniti di Foggia, Foggia/IT
  • 10Oncology, Presidio Ospedaliero Occidentale, Castellaneta/IT
  • 11Oncology, “Buccheri la Ferla Fatebenefratelli” Hospital, Palermo/IT
  • 12Oncology, Ospedale Cardarelli, Napoli/IT
  • 13Oncology, “S.G. Moscati” Hospital, Taranto/IT
  • 14Oncology, “Giovanni Paolo II” IRCCS, Bari/IT
  • 15Medical And Experimental Oncology Unit, Cancer Institute Giovanni Paolo II, Bari/IT
  • 16Oncology, “Sen. Perrino” Hospital, Brindisi/IT



ABC remains a therapeutic challenge in spite of the use of emerging new drugs. Nab-paclitaxel has better efficacy and no risk of hypersensitivity reactions when compared to paclitaxel. We studied the association of nab-paclitaxel and capecitabine in a novel schedule as I line treatment in a population of HER-2 negative and triple-negative ABC. An interim analysis was preplanned at 54 enrolled pts.


Nab-paclitaxel 150 mg/m2 was administered day 1 and 8 out of 21 days in combination with capecitabine at 825 mg/m2 twice daily, day 1-14 out of 21 days as first line therapy for HER2 negative ABC. The primary endpoints of the study are response rate (RR) and progression-free survival (PFS), secondary endpoints are toxicity and overall survival (OS).


Sixty five pts were enrolled from 11 centers, 59 pts (90.8%) evaluable for RR and PFS (ITT), 58 pts evaluable (89.2%) for toxicity. Median age was 56 years (34-77), 21 (32.3%) pts had triple-negative ABC, 44 pts (67.7%) hormone receptor positive ABC. Median number of metastatic site was 2 (range 1-5), visceral disease was present in 48 pts (73.9%). Median number of cycles was 6 (range 1-8). CR were 4 (6.8%), PR 31 (52.5%), for an overall RR (ORR) of 59.3%. SD was observed in 15 pts (25.4%), PD in 9 pts (15.3%). In the subpopulation of triple negative ORR was 50%. Median PFS for all pts was 43 weeks (26-48), 25 weeks (11-37) in triple-negative pts. Hematological toxicity Grade 3/4 was seen in 12/3 pts (18.5%/4.6%) (neutropenia G3/4 10/1 pts (15.4%/1.5%) and febrile neutropenia 2 pts (3%), respectively). Non-hematological toxicity grade 3/4 was seen in 11/10 pts (17%/15.4%), particularly neuropathy G3/4 1/0 (1.5%/0%).


Significant clinical activity and good tolerability was seen from the combination of nabpaclitaxel and capecitabine in HER-2 negative ABC. The study is ongoing, but data provide a basis to consider this regimen for further evaluation in phase III trials.


All authors have declared no conflicts of interest.