Irinotecan and oxaliplatin combination as the first-line treatment for patients with advanced non-small cell lung cancer.
BACKGROUND
We conducted a prospective phase II trial of IrOx in patients with advanced non-small cell lung cancer to evaluate the efficacy and toxicity.


METHODS
Patients with histologically or cytologically proven non-small cell lung cancer (NSCLC), aged > or =18 years, Eastern Cooperative Oncology Group performance status 0-1, at stage IIIB (pleural effusion)/IV or with recurrent disease not suitable for primary surgical treatment, with no palliative chemotherapy or radiotherapy to the chest or immunotherapy or biologic therapy, the presence of measurable disease by RECIST, and who had given signed written informed consent, were eligible. Treatment consisted of irinotecan 65 mg/m(2) on days 1 and 8 and oxaliplatin 130 mg/m(2) on day 1, repeated every 3 weeks.


RESULTS
A total of 18 patients were enrolled in June and August 2007, the median age was 59 years (47-73). In total, 71 cycles were administered with a median of 4 cycles per patient (range, 1-6 cycles) and 18 patients were evaluable for treatment response. An independent review of tumor responses gave an overall response rate of 27.7% (CR: 0, PR: 5/18; 95% CI, 7-48.4%) by intent-to-treat analysis. The median overall survival of all patients was 14 months and the median time-to-progression was 4.2 months (95% CI, 1.959-6.441). The most common grade 3/4 toxicities were diarrhea (7% of all cycles) and neutropenia (5.6% of all cycles). Grade 3 peripheral neuropathy occurred in one patient and one patient died due to sepsis.


CONCLUSIONS
This study suggests that IrOx combination therapy has moderate activity with a tolerable toxicity profile. However, it was not warranted to evaluate further this regimen as first-line treatment for patients with advanced or metastatic NSCLC using the current dosages and schedule.
Chang
Myung Hee
MH
Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Seoul, South Korea.
Kim
Kyoung Ha
KH
Jun
Hyun Jung
HJ
Kim
Hyo Song
HS
Yi
Seong Yoon
SY
Uhm
Ji Eun
JE
Park
Min Jae
MJ
Lim
Do Hyoung
DH
Ji
Sang Hoon
SH
Hwang
In Gyu
IG
Lee
Jeeyun
J
Park
Yeon Hee
YH
Ahn
Jin Seok
JS
Ahn
Myung-Ju
MJ
Park
Keunchil
K
D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D018450:Disease Progression; D005260:Female; D005838:Genotype; D014453:Glucuronosyltransferase / Q000235:genetics; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D011110:Polymorphism, Genetic; D016019:Survival Analysis
D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D000077146:Irinotecan; D014453:Glucuronosyltransferase; D002166:Camptothecin