Author of

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  P1.12 - Poster Session 1 - NSCLC Early Stage (ID 203)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10859

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    P1.12-009 - Oral vinorelbine in combination with cisplatin or carboplatin in adjuvant chemotherapy of non-small cell lung cancer: a prospective multicentre study of tolerability and survival. (ID 1476)

    09:30 - 09:30  |  Author(s): J. Svecova
    • Abstract

    Background
    Adjuvant cisplatinum-based chemotherapy is recommended for routine use in patients with stages IIA, IIB, and IIIA of non small-cell lung cancer (NSCLC) after radical resection. Results in stage IB were not conclusive. Vinorelbine is a preferable drug in this indication and a randomized study proved the comparable effectiveness and tolerability of vinorelbine given both orally or intravenously (i.v.) in advanced NSCLC, meanwhile oral vinorelbine gives better comfort to patients. Also tolerance of carboplatin (CBDCA) in better than tolerance of cisplatin (CDDP). Randomized studies in adjuvant chemotherapy (ACT) settings are missing.

    Methods
    This prospective multicenter study evaluates the tolerance and survival parameters of the ACT based on CDDP (75mg/m[2]) or CBDCA (AUC 5) with vinorelbine (25 mg/m[2] D1 i.v. and 35 mg/m2 D8 given orally). After radical resection, ACT (4 cycles of 21 day, out-patient regimen) was applied to patients with stage IB, II, and IIIA of NSCLC. Selection of CDDP or CBDCA was based on individual center preference. During the follow-up period of 42.2 months (m) survival was evaluated according to gender, smoking, age, tumor histology, stage and grading, surgical procedure, CDDP or CBDCA treatment.

    Results
    ACT was applied to 154 eligible patients (110 men, 44 women, median of age 63 years). Surgically determined stages were IB in 46 pts, II in 46 pts, and IIIA in 52 pts. CBDCA was given to 77 patients and CDDP to 77 patients,11 of whom switched to CBDCA due to toxicity. Mean age was 63.6 years in CBDCA group and 61.7 years in CDDP group. Altogether 586 cycles were administered, 82.6% of patients finished four cycles of planned ACT. Mean number of cycles was 3.79 per patient (3.76 in CDDP and 3.83 in CBDCA). The most frequent WHO grade 3/4 of toxicity were neutropenia in 16.8%, leucopenia in 7.9%, anemia in 1.2%, thrombocytopenia in 0.5%, alopecia in 2.9%, vomiting in 2.3%, neurotoxicity, diarrhoea and mucositis in 0.2% of cycles. Neutropenia, nausea and vomiting were more frequent in CDDP group. Relative dose intensity (RDI) was 94 % for vinorelbine i.v. and 88.6 % for vinorelbine p.o. In CBDCA RDI was significantly higher than CDDP (94 % vs 90 %, p 0.009). Three years overall survival (OS) was 68.2%, 5-year OS was 55.0% and 79 pts still live, 66 live without progression of the disease. OS was significantly longer in stage IB and II than in stage IIIA (p 0.007) and in CBDCA than CDDP treatment (p 0.01). Disease free survival (DFS) was 41.6 m, it was longer in men (p 0.049), in stage IB and II (p 0.041) and in DBDCA treatment (p 0.021).

    Conclusion
    Both applied regimen were tolerable. Survival was influenced by stage of the tumor. Patients treated with CBDCA experienced less toxicity, obtained higher RDI of planned treatment and lived longer than those treated with CDDP. Study showed that both CBDCA and CDDP can be used in combination with oral vinorelbine in ACT of NSCLC. This study was supported by Grant NT-13569 and NS-9959-3 of the Czech Ministry of Health