Prospective randomized study of four novel chemotherapy regimens in patients with advanced nonsmall cell lung carcinoma: a minnie pearl cancer research network trial.
BACKGROUND
The authors compared the toxicity, response rate, and progression free survival of four chemotherapy regimens for patients with advanced (Stage IIIB and IV) nonsmall cell lung carcinoma.


METHODS
A total of 267 patients entered this randomized Phase II trial on one of four arms: paclitaxel, carboplatin, and gemcitabine (Arm A); paclitaxel, carboplatin, and vinorelbine (Arm B); paclitaxel and gemcitabine (Arm C); and gemcitabine and vinorelbine (Arm D). Patient characteristics were similar in all treatment arms. At the time of tumor progression, patients were removed from study and were treated at the discretion of their physician.


RESULTS
Patients received a median of four courses of chemotherapy in all arms, and there was no difference in the dose delivered. There were no statistical differences in response rates (range, 32-45%), median progression free survival (range, 4.9-6.6 months), or progression free survival at 1 year (range, 8-19%). Actuarial survival in all four arms was not different, with a median survival ranging from 8.7 months to 10.7 months and a 1-year survival rate of 38-44%. Each arm was compared with a historic control with a median survival of 8 months. Arm D (gemcitabine and vinorelbine) approached significance at the 0.05 level.


CONCLUSIONS
Two-drug combinations containing the newer drugs without a platinum drug were less toxic than three-drug, platinum-based regimens. There were no significant differences in objective response rates or progression free survival when the four regimens were compared. The two-drug combination of gemcitabine and vinorelbine was the least toxic and, thus, may be superior. A Phase III trial comparing combined gemcitabine and vinorelbine with combined paclitaxel, carboplatin, and gemcitabine is ongoing.
Greco
F Anthony
FA
The Sarah Cannon Cancer Center and Tennessee Oncology, PLLC, Nashville 37203, USA. fgreco@tnonc.com
Gray
James R
JR
Thompson
Dana S
DS
Burris
Howard A
HA
Erland
Joan B
JB
Barton
John H
JH
Litchy
Sharlene
S
Houston
Gerry A
GA
Butts
James A
JA
Webb
Charles
C
Scott
Charles
C
Hainsworth
John D
JD
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D003841:Deoxycytidine; D014747:Vinblastine; D016190:Carboplatin; D017239:Paclitaxel; D000077235:Vinorelbine; D000093542:Gemcitabine