A phase II trial of concurrent chemotherapy with intravenous cisplatin and vinorelbine and radiotherapy followed by consolidation chemotherapy with oral vinorelbine in locally advanced non-small cell lung cancer (NSCLC): the CONCAVE study

Hughes, Brett G. M. , Ahern, Elizabeth, Lehman, Margot, Pratt, Gary, Dauth, Margaret, Pritchard, Wendy, Wockner, Leesa and Horwood, Keith (2017) A phase II trial of concurrent chemotherapy with intravenous cisplatin and vinorelbine and radiotherapy followed by consolidation chemotherapy with oral vinorelbine in locally advanced non-small cell lung cancer (NSCLC): the CONCAVE study. Asia Pacific Journal of Clinical Oncology, . doi:10.1111/ajco.12649


Author Hughes, Brett G. M.
Ahern, Elizabeth
Lehman, Margot
Pratt, Gary
Dauth, Margaret
Pritchard, Wendy
Wockner, Leesa
Horwood, Keith
Title A phase II trial of concurrent chemotherapy with intravenous cisplatin and vinorelbine and radiotherapy followed by consolidation chemotherapy with oral vinorelbine in locally advanced non-small cell lung cancer (NSCLC): the CONCAVE study
Journal name Asia Pacific Journal of Clinical Oncology   Check publisher's open access policy
ISSN 1743-7563
1743-7555
Publication date 2017-01-01
Sub-type Article (original research)
DOI 10.1111/ajco.12649
Open Access Status Not yet assessed
Total pages 8
Place of publication Chichester, West Sussex, United Kingdom
Publisher Wiley-Blackwell Publishing
Collection year 2018
Language eng
Formatted 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/m2 and vinorelbine IV 20 mg/m2 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/m2 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.
Keyword Chemoradiotherapy
Consolidation
Locally advanced
Lung cancer
Non-small cell
Vinorelbine
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
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