A randomized phase II study evaluating different maintenance schedules of nab-Paclitaxel in the first-line treatment of metastatic breast cancer: final results of the IBCSG 42-12/BIG 2-12 SNAP trial.

Gennari, A; Sun, Z; Hasler-Strub, U; Colleoni, M; Kennedy, M J; Von Moos, R; Cortés, J; Vidal, M J; Hennessy, B; Walshe, J; Amillano Parraga, K; Ribi, K; Bernhard, Jürg; Morales, S Murillo; Pagani, O; Barbeaux, A; Borstnar, S; Rabaglio, Manuela; Maibach, R; Regan, M M; ... (2018). A randomized phase II study evaluating different maintenance schedules of nab-Paclitaxel in the first-line treatment of metastatic breast cancer: final results of the IBCSG 42-12/BIG 2-12 SNAP trial. Annals of oncology, 29(3), pp. 661-668. Oxford University Press 10.1093/annonc/mdx772

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Background The phase II SNAP trial was designed to evaluate the efficacy of alternative chemotherapy schedules for prolonged administration in HER2-negative metastatic breast cancer (MBC), after a short induction at conventional doses. Methods Between April 2013 and August 2015, 258 women untreated with chemotherapy for MBC were randomly assigned to receive three different maintenance chemotherapy schedules after three cycles of identical induction chemotherapy: Arm A, nab-Paclitaxel 150 mg/m2 days 1,15 Q28; Arm B, nab-Paclitaxel 100 mg/m2 days 1,8,15 Q28; Arm C, nab-Paclitaxel 75 mg/m2 days 1,8,15,22 Q28. Induction was three cycles nab-Paclitaxel 150/125 mg/m2, days 1,8,15 Q28. The primary objective was to evaluate the efficacy of each maintenance schedule, in terms of progression-free survival (PFS), as compared to the historical reference of 7-month median PFS reported by previous studies with first-line docetaxel. One-sample, one-sided log-rank tests were utilized. Quality-of-life evaluation was performed, global indicator for physical well-being was defined as the primary endpoint; completion rates of quality-of-life forms were >90%. Results 255 patients were evaluable for the primary endpoint. After 18.2 months median follow-up, 182 PFS events were observed. Median PFS was 7.9 months (90%CI 6.8-8.4) in Arm A, 9.0 months (90%CI 8.1-10.9) in Arm B and 8.5 months (90%CI 6.7-9.5) in Arm C. PFS in Arm B was significantly longer than the historical reference of first-line docetaxel (P=0.03). Grade≥2 sensory neuropathy was reported in 37.9%, 36.1% and 31.2% of patients in Arm A, Arm B and Arm C, respectively (Grade≥3 in 9.1%, 5.6% and 6.6% of patients, respectively). Noteworthy, the quality-of-life scores for sensory neuropathy did not worsen with prolonged nab-Paclitaxel administration in any of the maintenance arms. Conclusion The SNAP trial demonstrated that alternative nab-Paclitaxel maintenance schedules with reduced dosages after a short induction at conventional doses are feasible and active in the first-line treatment of MBC. Registration ClinicalTrials.gov NCT01746225.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Medical Oncology

UniBE Contributor:

Bernhard, Jürg and Rabaglio, Manuela

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0923-7534

Publisher:

Oxford University Press

Language:

English

Submitter:

Nicole Corminboeuf

Date Deposited:

15 Feb 2018 16:36

Last Modified:

24 Oct 2019 09:20

Publisher DOI:

10.1093/annonc/mdx772

PubMed ID:

29228091

Uncontrolled Keywords:

Metastatic breast cancer alternative treatment schedules maintenance chemotherapy

BORIS DOI:

10.7892/boris.111307

URI:

https://boris.unibe.ch/id/eprint/111307

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