Open AccessPhase I study of cisplatin, vinorelbine, and concurrent thoracic radiotherapy for unresectable stage III non‐small cell lung cancer
Author(s) -
Sekine Ikuo,
Noda Kazumasa,
Oshita Fumihiro,
Yamada Kouzou,
Tanaka Manabu,
Yamashita Kosuke,
Nokihara Hiroshi,
Yamamoto Noboru,
Kunitoh Hideo,
Ohe Yuichiro,
Tamura Tomohide,
Kodama Tetsuro,
Sumi Minako,
Saijo Nagahiro
Publication year - 2004
Publication title -
cancer science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.035
H-Index - 141
eISSN - 1349-7006
pISSN - 1347-9032
DOI - 10.1111/j.1349-7006.2004.tb03331.x
Subject(s) - vinorelbine , medicine , lung cancer , esophagitis , regimen , cisplatin , stage (stratigraphy) , radiation therapy , chemotherapy , gastroenterology , toxicity , performance status , phases of clinical research , surgery , nuclear medicine , paleontology , disease , reflux , biology
To determine the recommended phase II dose of vinorelbine in combination with cisplatin and thoracic radiotherapy (TRT) in patients with unresectable stage III non‐small cell lung cancer (NSCLC), 18 patients received cisplatin (80 μg/m 2 ) on day 1 and vinorelbine (20 μg/m 2 in level 1, and 25 μg/m 2 in level 2) on days 1 and 8 every 4 weeks for 4 cycles. TRT consisted of a single dose of 2 Gy once daily for 3 weeks followed by a rest of 4 days, and then the same TRT for 3 weeks to a total dose of 60 Gy. Fifteen (83%) patients received 60 Gy of TRT and 14 (78%) patients received 4 cycles of chemotherapy. Ten (77%) of 13 patients at level 1 and all 5 patients at level 2 developed grade 3‐4 neutro‐penia. Four (31%) patients at level 1 and 3 (60%) patients at level 2 developed grade 3‐4 infection. None developed ≥grade 3 esophagitis or lung toxicity. Dose‐limiting toxicity was noted in 33% of the patients in level 1 and in 60% of the patients in level 2. The overall response rate (95% confidence interval) was 83% (59–96%) with 15 partial responses. The median survival time was 30.4 months, and the 1‐year, 2‐year, and 3‐year survival rates were 72%, 61%, and 50%, respectively. In conclusion, the recommended dose is the level 1 dose, and this regimen is feasible and promising in patients with stage III NSCLC.