Open-label, single-arm phase II study of pemetrexed in the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma who have had prior platinum-based chemotherapy.
BACKGROUND
This study was designed to evaluate the anti-tumor activity and toxicity of single agent pemetrexed in the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who had been treated with platinum-based chemotherapy.


METHODS
This is an open-label, single-arm phase II trial. All patients were treated with pemetrexed. Pemetrexed was given at the dosage of 500 mg/m(2) on day 1, with folic acid and vitamin B12 supplementation, each cycle repeated every 3 weeks. Treatment continued until patient had disease progression or unacceptable toxicities.


RESULTS
Thirty-five patients were enrolled in this trial. Thirty patients of total were suitable for tumor response assessment. One (2.9 %) patient achieved partial response (PR); 14 (40.0 %) patients, stable disease (SD); and 15 (42.9 %), progressed disease (PD). The progress-free survival (PFS) was 1.5 months (range, 1.5-14.4 months) and median overall survival (OS) was 13.3 months (95 % CI 8.2-18.4 months). Treatment was well tolerated in most patients. Only one patient (2.9 %) experienced grade 4 toxicity of thrombocytopenia and neutropenia. The most seen toxicities were neutropenia (37.1 %), aminotransferase increase (31.4 %), and rash (22.9 %).


CONCLUSIONS
Although pemetrexed induced a response in a patient, it has limited single-agent activity in advanced NPC patients pretreated with platinum-based chemotherapy.
State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, People's Republic of China.
Yang
Y
Zhang
Liping
L
Zhao
Peiyu
P
Huang
Jingxun
J
Wu
Fenghua
F
Wang
Yan
Y
Huang
Li
L
Zhang
D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002277:Carcinoma; D005260:Female; D005971:Glutamates / Q000009:adverse effects / Q000627:therapeutic use*; D006147:Guanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D000068437:Pemetrexed; D017671:Platinum Compounds / Q000627:therapeutic use; D016879:Salvage Therapy
D000964:Antimetabolites, Antineoplastic; D005971:Glutamates; D017671:Platinum Compounds; D000068437:Pemetrexed; D006147:Guanine