Docetaxel consolidation therapy following cisplatin, vinorelbine, and concurrent thoracic radiotherapy in patients with unresectable stage III non-small cell lung cancer.
BACKGROUND
To evaluate the feasibility and efficacy of docetaxel consolidation therapy after concurrent chemoradiotherapy for unresectable stage III non-small cell lung cancer (NSCLC).


METHODS
The eligibility criteria included unresectable stage III NSCLC, no previous treatment, age between 20 and 74 years, and performance status 0 or 1. Treatment consisted of cisplatin (80 mg/m2 on days 1, 29, and 57), vinorelbine (20 mg/m2 on days 1, 8, 29, 36, 57, and 64), and thoracic radiotherapy (TRT) (60 Gy/30 fractions over 6 weeks starting on day 2), followed by consolidation docetaxel (60 mg/m2 every 3 to 4 weeks for three cycles).


RESULTS
Of 97 patients who were enrolled in this study between 2001 and 2003, 93 (76 males and 17 females with a median age of 60) could be evaluated. Chemoradiotherapy was well tolerated; three cycles of chemotherapy and 60 Gy of TRT were administered in 80 (86%) and 87 (94%) patients, respectively. Grade 3 or 4 neutropenia, esophagitis, and pneumonitis developed in 62, 11, and 3 patients, respectively. Docetaxel consolidation was administered in 59 (63%) patients, but three cycles were completed in only 34 (37%) patients. The most common reason for discontinuation was pneumonitis, which developed in 14 (24%) of the 59 patients. During consolidation therapy, grade 3 or 4 neutropenia, esophagitis, and pneumonitis developed in 51, 2, and 4 patients, respectively. A total of four patients died of pneumonitis. We calculated a V20 (the percent volume of the normal lung receiving 20 Gy or more) on a dose-volume histogram in 25 patients. Of these, five patients developed grade 3 or more severe radiation pneumonitis. A median V20 for these five patients was 35% (range, 26-40%), whereas the median V20 for the remaining 20 patients was 30% (range, 17-35%) (p = 0.035 by a Mann-Whitney test). The response rate was 81.7% (95% confidence interval [CI], 72.7-88.0%), with 5 complete and 71 partial responses. The median progression-free survival was 12.8 (CI, 10.2-15.4) months, and median survival was 30.4 (CI, 24.5-36.3) months. The 1-, 2-, and 3-year survival rates were 80.7, 60.2, and 42.6%, respectively.


CONCLUSIONS
This regimen produced promising overall survival in patients with stage III NSCLC, but the vast majority of patients could not continue with the docetaxel consolidation because of toxicity.
Sekine
Ikuo
I
Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan. isekine@ncc.go.jp
Nokihara
Hiroshi
H
Sumi
Minako
M
Saijo
Nagahiro
N
Nishiwaki
Yutaka
Y
Ishikura
Satoshi
S
Mori
Kiyoshi
K
Tsukiyama
Iwao
I
Tamura
Tomohide
T
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D002945:Cisplatin / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D008297:Male; D008875:Middle Aged; D011832:Radiation Injuries; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
D043823:Taxoids; D000077143:Docetaxel; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine