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J. Chalupa



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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
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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. Chalupa

      • 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

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    P2.12 - Poster Session 2 - NSCLC Early Stage (ID 205)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.12-009 - Adjuvant chemotherapy with oral vinorelbine used in doublet with carboplatin in non-small cell lung cancer after radical resection - tolerability and short term survival. (ID 1244)

      09:30 - 09:30  |  Author(s): J. Chalupa

      • 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. Only few studies evaluated the position of vinorelbine in doublet with carboplatin (CBDCA) none of them used oral vinorelbine in this doublet as adjuvant chemotherapy (ACT).

      Methods
      This prospective multicentre study evaluates the feasibility, toxicity and short time survival of ACT based on CBDCA (AUC 5) with oral vinorelbine after radical resection. Vinorelbine was applied orally 80 mg/m[2] D1 and D8 after the first cycle of 60mg/m[2]. ACT (4 cycles of 21 day regimen) was applied to patients with stage IB, II, and IIIA of NSCLC (6[th] TNM revision) in 16 centres. Therapy was applied from the 1[st] of April 2009 to the 28[th] of February 2010. Median of follow-up period was 31 months Histology of tumor, type of surgery, grading, visceral pleura and angio-invasion were evaluated as potencial predictors of survival.

      Results
      ACT was applied to 104 eligible patients (72 men, 32 women, median of age 64 years). Out of them 41 were smokers, 57 ex-smokers and 5 non smokers. Surgically determined stages were IB in 32 pts, II in 36 pts and IIIA in 36 pts. Altogether 399.5 cycles (mean no 3.82) were administered, 86,5 % of patients finished four cycles of planned ACT. The reasons for 14 (13.5%) patients ending ACT prematurely were hematological toxicity in 8 pts, non-hematological toxicity in 3 pts, other reasons in 3 pts . Relative dose intensity (RDI) was 80.8% for vinorelbine and 95.4% for CBDCA. The most frequent WHO grade 3/4 of toxicity were neutropenia in 10.6%, leucopenia in 5.6%, anemia in 1.3%, thrombocytopenia in 1.3%, alopecia in 3.3%, nausea in 4.8%, neurotoxicity, nephrotoxicity, diarrhoea and mucositis in 0.3%. During the median of follow-up period, 45 (43.2%) pts died and 38 (36.5%) out of them died on lung cancer. Median DFS was 29.1 months, 2-year survival was 70.6%, 2.5-year survival was 63.9%. Predictors of significantly better DFS and 2.5 year survival were stage IB (p = 0.0045) and lobectomy (p = 0.0465). Trend of better DFS and 2.5 year survival was observed in cases without angioinvasion and pleural invasion.

      Conclusion
      Applied ACT had excellent tolerability, high RDI was achieved and preliminary parameters of survival are acceptable. Study is ongoing and long term survival results will be evaluated in the future. This study was supported by Grant NT- 13569 and NS-9959-3 of the Czech Ministry of Health