Concurrent chemoradiation with cisplatin and vinorelbine followed by consolidation with oral vinorelbine in locally advanced non‐small cell lung cancer (NSCLC): the phase II CONCAVE study. Issue 3 (9th February 2017)

• Record Type: Journal Article
• Authors: Hughes, Brett GM; Ahern, Elizabeth; Lehman, Margot; Pratt, Gary; Dauth, Margaret; Pritchard, Wendy; Wockner, Leesa; Horwood, Keith
• Is Part Of: Asia-Pacific journal of clinical oncology. Volume 13:Issue 3(2017)
• Page Start: 137
• Page End: 144
• Publication Date: 2017-02-09
• Subjects: chemoradiotherapy -- consolidation -- locally advanced -- lung cancer -- non–small cell -- vinorelbine; Oncology -- Pacific Area -- Periodicals; Cancer -- Treatment -- Pacific Area -- Periodicals; Cancer -- Pacific Area -- Periodicals; Cancer -- Treatment -- Periodicals; 616.9940095
• DOI: 10.1111/ajco.12649
• Languages: English
• ISSNs: 1743-7555

Abstract

Abstract: Aim: Despite recent advances, outcomes for patients with stage III non–small cell lung cancer (NSCLC) with concurrent chemoradiotherapy (CRT) remain poor. We evaluated the combination of ciplatin/vinorelbine and concurrent thoracic radiotherapy followed by consolidation oral vinorelbine in this phase II study. Methods: Eligible patients with unresectable stage III NSCLC received cisplatin intravenous (IV) 40 mg/m 2 and vinorelbine IV 20 mg/m 2 on days 1, 8, 22 and 29 concurrent with thoracic radiotherapy of 60 Gy in 30 fractions. Four to eight weeks later, oral vinorelbine 60 mg/m 2 day 1 and 8 every 3 weeks was given for 3 cycles. The primary end point was overall response rate (ORR). Secondary end points were safety, quality of life, progression‐free survival (PFS) and overall survival (OS). Results: Twenty‐seven eligible patients were enrolled from December 2007 to June 2010 before the trial was prematurely closed due to toxicity concerns. The median age was 63 years (range, 42–71), 56% were male, 52% ECOG 0 and 52% stage IIIa. The ORR was 81% (including 37% complete response rate) and disease control rate of 93%. The median PFS was 11 months and median OS was 26 months. Consolidation vinorelbine was associated with significant grade 3/4 toxicity (68%) including grade 3–5 febrile neutropenia (27%) and respiratory infections (36%) including two deaths in the consolidation phase (9%). Conclusions: Consolidation oral vinorelbine after CRT was associated with significant toxicity. Overall, this regimen achieved a high ORR and survival results comparable to other CRT protocols but the significant toxicity precludes further evaluation of this approach.