Induction Cisplatin Docetaxel Followed by Surgery and Erlotinib in Non-Small Cell Lung Cancer
Tina Cascone, Kathryn A Gold, Stephen G Swisher, Diane D Liu, Frank V Fossella, Boris Sepesi, Apar Pataer, Annikka Weissferdt, Neda Kalhor, Ara A Vaporciyan, Wayne L Hofstetter, Ignacio I Wistuba, John V Heymach, Edward S Kim, William N William Jr, Tina Cascone, Kathryn A Gold, Stephen G Swisher, Diane D Liu, Frank V Fossella, Boris Sepesi, Apar Pataer, Annikka Weissferdt, Neda Kalhor, Ara A Vaporciyan, Wayne L Hofstetter, Ignacio I Wistuba, John V Heymach, Edward S Kim, William N William Jr
Abstract
Background: Data from meta-analyses support the use of induction or adjuvant platinum-based chemotherapy for locally advanced non-small cell lung cancers (NSCLCs). This phase 2 study assessed the role of induction cisplatin and docetaxel followed by surgery in patients with resectable stage I to III NSCLCs, followed by 12 months of adjuvant erlotinib.
Methods: Patients with resectable stage I to III NSCLCs received cisplatin 80 mg/m2, docetaxel 75 mg/m2 every 21 days for 3 cycles, followed by surgery, followed by adjuvant erlotinib for 12 months. The primary endpoint included safety. Long-term efficacy outcomes and exploratory analysis of intermediary endpoints are also reported (NCT00254384).
Results: Forty-seven eligible patients received a median of 3 cycles of induction treatment, 37 underwent surgical resection, and only 21 received adjuvant erlotinib. Two patients died in the perioperative period (1 sepsis during chemotherapy, 1 acute respiratory distress syndrome postoperatively). Most common grade 3 to 5 toxicities during chemotherapy included hypokalemia (8%), infection (7%), and granulocytopenia (25%). During adjuvant erlotinib, 14% of patients experienced grade 2 rash. Median overall survival was 3.4 years. Major pathologic responses in the primary tumor were observed in 19% (7 of 37) of patients and correlated with improved long-term overall survival. Complete pathologic response in mediastinal/hilar nodes also correlated with superior survival.
Conclusions: Induction cisplatin and docetaxel was well tolerated. Adjuvant erlotinib did not improve outcomes compared with historical controls. Major pathologic response predicted for improved long-term survival and is a suitable intermediary endpoint for future phase 2 studies.
Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
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Source: PubMed