Dose-dense Paclitaxel and Carboplatin as Neoadjuvant Chemotherapy for Stage IIB/IIIA Non-small Cell Lung Cancer – A Phase II trial. Issue 12 (December 2021)

• Record Type: Journal Article
• Authors: Mittal, A.; Malik, P.S.; Kumar, S.; Saikia, J.; Chitikela, S.; Khurana, S.; Bharti, S.; Jain, D.; Pathy, S.; Thulkar, S.; Kumar, R.; Madan, K.; Mohan, A.
• Is Part Of: Clinical oncology. Volume 33:Issue 12(2021)
• Page Start: e553
• Page End: e560
• Publication Date: 2021-12
• Subjects: chemoimmunotherapy -- dose-dense chemotherapy -- locally advanced NSCLC -- objective response rate -- potentially resectable NSCLC; Oncology -- Periodicals; Tumors -- Periodicals; Cancer -- Treatment -- Periodicals; Radiotherapy -- Periodicals; Neoplasms -- Periodicals; Cancer -- Radiotherapy; Cancer -- Treatment; Oncology; Medical radiology; Radiotherapy; Tumors; Electronic journals; Periodicals; 616.994
• DOI: 10.1016/j.clon.2021.07.008
• Languages: English
• ISSNs: 0936-6555

Abstract

Abstract: Aims: The approach to potentially resectable non-small cell lung cancer (NSCLC) remains controversial. There is a benefit of neoadjuvant chemotherapy (NACT), but the ideal regimen is unknown. We evaluated the efficacy and safety of dose-dense NACT in potentially resectable NSCLC in this phase II trial. Materials and methods: Paclitaxel at 80 mg/m 2 on days 1, 8 and 15 with AUC-6 carboplatin on day 1, 3 weekly for four cycles was evaluated as NACT. Patients with Eastern Cooperative Oncology Group performance status 0–2, stage IIB and IIIA (with only non-bulky N2 nodes) were included. The primary end point was the objective response rate. Secondary end points included toxicity, progression-free survival, recurrence-free survival, complete resection rate and overall survival. The relative dose intensity (RDI) was calculated to define tolerability (CTRI/2016/05/006916). Results: In total, 37 patients were enrolled (median age 55 years). Most (78.8%) were smokers. Most patients had adenocarcinoma (57.6%) and stage IIIA disease (81.0%) according to the seventh American Joint Committee on Cancer staging system. Seventy-eight per cent of patients completed four cycles. The objective response rate was 75.6% with a complete response in 10.8%. The mean RDI of paclitaxel was 88.61%, with 68.0% of patients able to maintain an RDI ≥85.0%. In total, 187 toxicity events were recorded (120 grade 1, 64 grade 2 and three grade 3 events). Common toxicities were peripheral neuropathy (20.3%), myalgia (19.8%), nausea (15.7%) and neutropenia (10.2%). There were no treatment-related deaths. Seventeen patients underwent surgery (lobectomy 82.4%). After a median follow-up of 47 months (95% confidence interval 27–50.7 months), the median progression-free survival was 9.6 months (7.4–17.4) and overall survival was 29.2 months (16.0–37.2). Conclusion: Dose-dense paclitaxel–carboplatin is feasible, safe and efficacious and should be evaluated further in potentially resectable NSCLC. Highlights: First study to use dose-dense neoadjuvant chemotherapy in potentially resectable NSCLC. 78% patients completed planned treatment with mean RDI of 88%. Only three patients had grade 3 toxicity demonstrating safety. ORR of 75.68% was comparable with previously used neoadjuvant approaches. This approach may be used as one of the neoadjuvant chemotherapy regimens for potentially resectable NSCLC.