A randomized phase 2 study of pemetrexed in combination with cisplatin or carboplatin as adjuvant chemotherapy in patients with completely resected stage IB or II non-small-cell lung cancer
We investigated the feasibility of cisplatin or carboplatin combined with pemetrexed as adjuvant treatment in patients with completely resected Stage IB/II Non-Small-Cell Lung Cancer (NSCLC). Patients in this multicenter, open-label, parallel-group, non-comparative Phase 2 study were randomized (1:1...
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| Main Author: | |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
December 2015
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| In: |
Lung cancer
Year: 2015, Volume: 90, Issue: 3, Pages: 397-404 |
| ISSN: | 1872-8332 |
| DOI: | 10.1016/j.lungcan.2015.11.007 |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1016/j.lungcan.2015.11.007 Verlag, Volltext: http://www.sciencedirect.com/science/article/pii/S0169500215301021 
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| Author Notes: | Gerald Schmid-Bindert, Walburga Engel-Riedel, Martin Reck, Wolfgang Schuette, Jan Stöhlmacher, Jürgen R. Fischer, Julien Mazières, Christos Chouaid, Martin Wolf, Nuria Vinolas, Victoria Soldatenkova, Veronique Ripoche, Tuan Nguyen, Carla Visseren-Grul |
| Summary: | We investigated the feasibility of cisplatin or carboplatin combined with pemetrexed as adjuvant treatment in patients with completely resected Stage IB/II Non-Small-Cell Lung Cancer (NSCLC). Patients in this multicenter, open-label, parallel-group, non-comparative Phase 2 study were randomized (1:1) to pemetrexed (500mg/m2) with either cisplatin (75mg/m2) or carboplatin (AUC5) for 4 cycles of 21 days. The primary endpoint was treatment feasibility (defined as 4 cycles completed with no cycle delay >42 days and ≤2 dose reductions, with a median relative dose intensity (RDI) ≥95% [overall]; and no Grade ≥3 toxicities at the follow-up visit 30 days after last drug administration). Secondary objectives included overall survival (OS) and safety. We randomized 122 patients and treated 118. 71.9% (46/64) of patients in pemetrexed+cisplatin and 88.9% (48/54) in pemetrexed+carboplatin completed 4 cycles (median RDI >97% for all compounds). Neither treatment met the pre-defined feasibility level >60% of patients: 59.4% (95% confidence interval [CI]: 46.4;71.5) pemetrexed+cisplatin; 50.0% (95%CI: 36.1;63.9) in pemetrexed+carboplatin. In a post-hoc analysis considering only safety, both regimens were feasible with 81.3% (95%CI: 69.5;89.9) in pemetrexed+cisplatin and 90.7% (95%CI: 79.7;96.9) in pemetrexed+carboplatin. OS rates for both groups were 82-83% after 3 years and 80-83% after 5 years. Treatment-related Grade ≥3 adverse events (mostly hematological) were experienced by approximately 30% of patients in each group. Although the study did not meet the primary objective, both treatment groups demonstrated good safety-related feasibility and tolerability as adjuvant treatment in patients with completely resected Stage IB/II NSCLC. |
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| Item Description: | Gesehen am 26.10.2017 |
| Physical Description: | Online Resource |
| ISSN: | 1872-8332 |
| DOI: | 10.1016/j.lungcan.2015.11.007 |