Temozolomide: a safe and effective treatment for malignant digestive endocrine tumors.
BACKGROUND
Systemic chemotherapies are associated with limited response rates and significant toxicity in patients with malignant digestive endocrine tumors (DET). Preliminary studies have reported interesting results with temozolomide in patients with DET.


OBJECTIVE
It was the aim of this study to assess the efficacy and safety of temozolomide in patients with malignant DET.


METHODS
Twenty-one patients, median age 61 years (range 56-77), with metastatic well-differentiated DET were retrospectively studied. All patients except 1 had received prior treatment (hepatic resection, chemotherapy). All patients had progressive disease in the 3 months prior to entry into the study. Temozolomide was administered at doses of 200 mg/m(2) daily for 5 days, every 28 days. Treatment was assessed for safety, progression-free and overall survival.


RESULTS
The median number of temozolomide cycles was 5 (range 2-15). Grade 3 hematological toxicity occurred in 5 patients. There were no toxic deaths. According to the Response Evaluation Criteria in Solid Tumors criteria, partial response and stabilization were obtained in 1 (5%) and 17 patients (81%), respectively. The median time to progression was 9 months (range 3-26). The 1-year progression-free survival and overall survival were 42 and 77%, respectively.


CONCLUSIONS
Temozolomide is a well-tolerated oral chemotherapy in patients with malignant DET, including those who have already received treatment. In patients with progressive disease, temozolomide controls tumor progression in 86% of cases.
Maire
Frédérique
F
Pôle des Maladies de l'Appareil Digestif, Service de Gastroentérologie-Pancréatologie, Hôpital Beaujon, Clichy, France. frederique.maire@bjn.aphp.fr
Hammel
Pascal
P
Faivre
Sandrine
S
Hentic
Olivia
O
Yapur
Lorena
L
Larroque
Béatrice
B
Couvelard
Anne
A
Zappa
Magaly
M
Raymond
Eric
E
Lévy
Philippe
P
Ruszniewski
Philippe
P
D000368:Aged; D000704:Analysis of Variance; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D002276:Carcinoid Tumor / Q000188:drug therapy; D003606:Dacarbazine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004067:Digestive System Neoplasms / Q000188:drug therapy* / Q000401:mortality; D018450:Disease Progression; D004701:Endocrine Gland Neoplasms / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D000077204:Temozolomide; D013997:Time Factors; D016896:Treatment Outcome
D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide