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Multicenter Study
. 2017 Jul 21;12(7):e0181803.
doi: 10.1371/journal.pone.0181803. eCollection 2017.

Carboplatin with intravenous and subsequent oral administration of vinorelbine in resected non-small-cell-lung cancer in real-world set-up

Vítězslav Kolek  1 , Ivona Grygárková  1 , Leona Koubková  2 , Jana Skřičková  3 , Jiřina Švecová  4 , Dimka Sixtová  5 , Jiří Bartoš  6 , Aleš Tichopád  7
Affiliations
Multicenter Study

Carboplatin with intravenous and subsequent oral administration of vinorelbine in resected non-small-cell-lung cancer in real-world set-up

Vítězslav Kolek et al. PLoS One. .

Abstract

Objectives: Adjuvant cisplatin-based chemotherapy is recommended for routine use in patients with Stage IIA, IIB or IIIA non-small cell lung cancer (NSCLC) after complete resection. Results obtained for Stage IB were not conclusive. While vinorelbine plus cisplatin is the preferred choice after resection, combining vinorelbine with carboplatin promises improved compliance and delivery of drugs due to lower toxicity. We evaluated the impact of this option on treatment compliance and survival under real-world conditions.

Material and methods: A prospective, single-arm, multicenter, non-interventional study evaluated the tolerability, dose intensity and survival resulting from adjuvant use of intravenous carboplatin (AUC 5 on day 1) with vinorelbine administered both intravenously (25 mg/m2 on day 1) and orally (60 mg/m2 on day 8) within four cycles of 21 days each. A total of 74 patients with a median age of 64 years were observed.

Results: The mean number of accomplished cycles was 3.78, and 62 patients (83.7%) completed all four planned cycles. Relative dose intensity for carboplatin was 88.9%, for intravenous vinorelbine 93.1%, and for oral vinorelbine 83.2%. Median follow-up was 4.73 years. Median disease-specific survival (DSS) was 7.63 years, median overall survival (OS) was 5.90 years, median disease-free survival (DFS0) was 4.43 years, and five-year survival was 56.2%. TNM stage of disease significantly affected DSS and OS. Favorable survival was observed in females, nonsmokers, patients aged over 65 years, patient with prior lobectomy, patients with tumor of squamous histology, and those who finished the planned therapy, but the differences were non-significant.

Conclusion: Adjuvant carboplatin with vinorelbine switched from intravenous to oral administration was shown to be a favorable regimen with regard to tolerability and safety. Compliance to therapy was high, and survival parameters were promising, showing that applied regimen can be another potential option for adjuvant chemotherapy in patients with NSCLC.

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Conflict of interest statement

Competing Interests: This was an open label, non-interventional, investigator-driven study performed at the investigators´ sites. There are no competing interests in this application. The statement also applies for Aleš Tichopád as an employee of Kantar Health, a contract research organization specialized in Real-world-research services. This commercial affiliation does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Overall survival and disease specific survival.
Fig 2
Fig 2. Overall survival by disease stage.
Fig 3
Fig 3. Tree plot showing percentage of 5-year overall survival with 95% confidence limits.
Data presented in Fig 3 are derived from Table 1.
See this image and copyright information in PMC

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