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.
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BORIS DOI
Date of Publication
March 1, 2018
Publication Type
Article
Division/Institute
Contributor
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 | |
Morales, S Murillo | |
Pagani, O | |
Barbeaux, A | |
Borstnar, S | |
Maibach, R | |
Regan, M M | |
Jerusalem, G |
Subject(s)
Series
Annals of oncology
ISSN or ISBN (if monograph)
0923-7534
Publisher
Oxford University Press
Language
English
Publisher DOI
PubMed ID
29228091
Uncontrolled Keywords
Description
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to evaluate the efficacy of each maintenance schedule, in terms of progression-free survival (PFS), as compared to the historical reference of 7-month median PFS reported by previous studies with first-line docetaxel.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(90%CI 8.1-10.9) in Arm B and 8.5 months (90%CI 6.7-9.5) in Arm C. PFS in Arm B was significantly longer than the historical reference of first-line docetaxel (P=0.03).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.
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.
File(s)
| File | File Type | Format | Size | License | Publisher/Copright statement | Content | |
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| Unbenannt2.pdf | text | Adobe PDF | 663.06 KB | publisher | accepted | ||
| mdx772.pdf | text | Adobe PDF | 330.71 KB | publisher | published |