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- W2035362501 abstract "IntroductionCisplatin in combination with vinorelbine has reported an optimal activity/tolerance ratio when used in combination with radiotherapy in locally advanced unresectable non-small cell lung cancer. The currently available oral formulation of vinorelbine should be easier to use assuming a similar activity profile. An international phase II trial with vinorelbine oral and cisplatin as induction followed by oral vinorelbine and cisplatin with concomitant radiotherapy was implemented to evaluate the efficacy in terms of objective response (OR) following this combination as primary end point and duration or response, progression-free survival, overall survival, and safety as secondary endpoints.Material and MethodsThe study included patients between 18 and 75 years, with histologically proven untreated locally advanced inoperable stage IIIA/IIIB (supraclavicular lymph nodes and pleural effusion excluded) non-small cell lung cancer, adequate bone marrow, hepatic and renal function, Karnofsky performance status ≥80%. Patients were treated with oral vinorelbine 60 mg/m2 day 1,8 cycle 1 and 80 mg/m2 day 1,8 cycle 2 (if no grade 3-4 toxicity) and cisplatin 80 mg/m2 day 1 every 3 weeks for 2 cycles as induction. Patients without progression received oral vinorelbine 40 mg/m2 day 1, 8 and cisplatin 80 mg/m2 day 1 every 3 weeks for 2 more cycles with radiotherapy 66 Gy in 6.5 weeks.ResultsPatient and disease characteristics (n = 54) included: median age 57 years; female sex 24%; stage IIIA 48% and IIIB 52%; Squamous carcinoma 59%, Karnofsky performance status 100% (range, 80-100%) 50%, patients ≥5% weight loss at baseline 7%. Relative dose intensities of oral vinorelbine/cisplatin were 86%/93% and 97%/98% at induction and in combination with radiotherapy, respectively. Forty-one patients (76%) increased oral vinorelbine from 60 to 80 mg/m2 day during induction (reasons for nonescalation: hematological 7 patients, nonhematological 2 patients, error 4 patients). After two cycles of chemotherapy induction, the OR intent-to-treat in the 54 patients was 37%. Toxicities during induction were as follows: Neutropenia G3-4 (28%), Febrile Neutropenia (7%), nausea G3 (11%), vomiting G3-4 (9%), anorexia G3 (4%), diarrhea G4 (2%), constipation G3 (2%). Forty-seven out of 54 (87%) patients received concomitant chemo-radiotherapy.Median radiotherapy delivered dose was 66 Gy. Tolerance: 9% G3 Neutropenia; 4% G3 dysphagia/radiation; 2% G3 radiation dermatitis. Late pulmonary fibrosis was reported in one patient (1.8%). One month after completion of chemo-radiotherapy, the overall OR intent-to-treat in the 54 patients was 54% (95% CI: 40-67%). With a median follow-up of 37 months (95% CI: 34-41) the median progression-free survival and overall survival were: 12.5 (95% CI: 9.6-16.4) and 23.4 (95% CI: 17.6-29.8) months, respectively.ConclusionOral vinorelbine in combination with cisplatin is an effective combination in stage IIIA/IIIB patients. The excellent tolerance profile allowed to complete concomitant chemo-radiotherapy in 87% of patients. Oral vinorelbine in combination with cisplatin is a new and promising option that facilitates the administration of concomitant chemo-radiotherapy with high rates of treatment completion." @default.
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- W2035362501 date "2008-09-01" @default.
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- W2035362501 title "Oral Vinorelbine and Cisplatin as Induction Chemotherapy and Concomitant Chemo-Radiotherapy in Stage III Non-small Cell Lung Cancer: Final Results of an International Phase II Trial" @default.
- W2035362501 cites W1944220675 @default.
- W2035362501 cites W1977994425 @default.
- W2035362501 cites W1984254136 @default.
- W2035362501 cites W1995634658 @default.
- W2035362501 cites W2019749043 @default.
- W2035362501 cites W2026097725 @default.
- W2035362501 cites W2035704169 @default.
- W2035362501 cites W2037587586 @default.
- W2035362501 cites W2039459719 @default.
- W2035362501 cites W2045783213 @default.
- W2035362501 cites W2051767374 @default.
- W2035362501 cites W2060985892 @default.
- W2035362501 cites W2081186807 @default.
- W2035362501 cites W2084800358 @default.
- W2035362501 cites W2086237017 @default.
- W2035362501 cites W2104325484 @default.
- W2035362501 cites W2104945409 @default.
- W2035362501 cites W2105969273 @default.
- W2035362501 cites W2113003672 @default.
- W2035362501 cites W2127596453 @default.
- W2035362501 cites W2129793485 @default.
- W2035362501 cites W2131928292 @default.
- W2035362501 cites W2138310931 @default.
- W2035362501 cites W2147839112 @default.
- W2035362501 cites W2152973202 @default.
- W2035362501 cites W2160878716 @default.
- W2035362501 cites W2169518833 @default.
- W2035362501 cites W2176864701 @default.
- W2035362501 cites W2256453366 @default.
- W2035362501 cites W2278556698 @default.
- W2035362501 cites W2331910443 @default.
- W2035362501 cites W4235170956 @default.
- W2035362501 cites W4237288361 @default.
- W2035362501 cites W4239676301 @default.
- W2035362501 doi "https://doi.org/10.1097/jto.0b013e31818396cb" @default.
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