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A Phase II pilot trial of 13‐cis retinoic acid and interferon‐α in patients with advanced pancreatic carcinoma
Author(s) -
Brembeck Felix H.,
Schoppmeyer Klaus,
Leupold Ursula,
Gornistu Costel,
Keim Volker,
Mössner Joachim,
Riecken ErnstOtto,
Rosewicz Stefan
Publication year - 1998
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/(sici)1097-0142(19981201)83:11<2317::aid-cncr11>3.0.co;2-p
Subject(s) - medicine , gastroenterology , tolerability , adenocarcinoma , carcinoma , pancreatic disease , toxicity , surgery , cancer , pancreas , adverse effect
BACKGROUND Advanced unresectable pancreatic adenocarcinoma has a dismal prognosis. The authors previously have shown that retinoic acid (RA) and interferon‐α (IFN‐α) inhibit growth and induce differentiation in human pancreatic carcinoma cells in vitro and in vivo. The purpose of this trial was to examine the feasibility and tolerability of a combination therapy of 13‐cis RA and IFN‐α in patients with advanced unresectable pancreatic carcinoma. METHODS Twenty‐two patients (median age, 62 years) with histologically confirmed, unresectable pancreatic adenocarcinoma classified as International Union Against Cancer Stage III (5 patients) or IV (17 patients) were included. Patients received 1 mg/kg body weight 13‐cis RA orally and 6 million IU IFN‐α subcutaneously daily. Restaging by ultrasound, computed tomography scan, and chest X‐ray was performed every 2 months. RESULTS No complete remission and 1 partial remission (PR) (4.5%) were observed. Fourteen patients (63.6%) demonstrated stable disease with a median duration of 5.0 months (range, 2.3‐17.7+ months). Toxicity mainly was related to IFN‐α and predominantly was hematologic (no toxicity was World Health Organization [WHO] Grade 4 and 13.6% were WHO Grade 3). Nonhematologic toxicities did not exceed Grade 2 (skin and oral mucosa) and mainly were related to 13‐cis RA. The median survival of the patients with Stage III disease was 8.7 months (range, 6.8‐23.9+ months) and was 7.4 months for patients with Stage IV disease (range, 0.9‐19.2+ months), resulting in a median overall survival of 7.7 months (range, 0.9‐23.9+ months). CONCLUSIONS Combination therapy with 13‐cis RA and IFN‐α is feasible and well tolerated in patients with advanced pancreatic carcinoma. Based on the median survival rates observed in this study this combination should be investigated further in Phase III trials. Cancer 1998;83:2317‐2323. © 1998 American Cancer Society.