Dose-Escalation Study of Thoracic Radiotherapy in Combination With Pemetrexed Plus Cisplatin in Japanese Patients With Locally Advanced Nonsquamous Non-Small Cell Lung Cancer: A Post Hoc Analysis of Survival and Recurrent Sites.
OBJECTIVE
We performed a post hoc analysis of progression-free survival (PFS), overall survival (OS), and recurrent sites in patients with locally advanced nonsquamous non-small cell lung cancer who were enrolled in a phase I trial of combination chemotherapy consisting of pemetrexed plus cisplatin with concurrent thoracic radiotherapy.


METHODS
Patients received pemetrexed (500 mg/m²) plus cisplatin (75 mg/m²) on day 1 every 3 weeks for 3 cycles plus concurrent thoracic radiotherapy consisting of 60 Gy (n=6) or 66 Gy (n=12); 4 to 6 weeks thereafter, patients received consolidation treatment with pemetrexed (500 mg/m) every 3 weeks for up to 3 cycles. We reviewed the medial records to collect data on progression, recurrent sites, late toxicity, and survival.


RESULTS
No late radiation morbidity was observed. Thirteen patients (72%) exhibited disease progression: 8 patients had distant metastases, 8 patients had local recurrence (within the radiation field [n=6], outside the radiation field [n=2], and both [n=1]), and 3 patients had local recurrence plus distant metastases. The median PFS was 10.5 months (95% confidence interval [CI], 8.8-12.3), and the 3-year PFS rate was 28% (95% CI, 7.0-48.6). Ten of the 18 patients died of lung cancer. The median follow-up time for the censored cases was 42.8 months (range, 38.1 to 52.9 mo). The median OS was 27.3 months (95% CI, 13.1-41.6), and the 3-year OS rate was 50% (95% CI, 26.9-73.1).


CONCLUSIONS
The median PFS and OS in our study were comparable to those of historical chemoradiotherapy controls.
Departments of *Thoracic Oncology ‡Radiation Oncology, National Cancer Center Hospital East, Chiba Departments of †Thoracic Oncology §Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan.
Seiji
S
Niho
Hiroshi
H
Nokihara
Keiji
K
Nihei
Tetsuo
T
Akimoto
Minako
M
Sumi
Yoshinori
Y
Ito
Kiyotaka
K
Yoh
Koichi
K
Goto
Hironobu
H
Ohmatsu
Hidehito
H
Horinouchi
Noboru
N
Yamamoto
Ikuo
I
Sekine
Kaoru
K
Kubota
Yuichiro
Y
Ohe
Tomohide
T
Tamura
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000628:therapy*; D059248:Chemoradiotherapy / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000473:pathology; D000068437:Pemetrexed / Q000008:administration & dosage; D011879:Radiotherapy Dosage
D000068437:Pemetrexed; D002945:Cisplatin