title: [Erlotinib plus gemcitabine combination therapy in patients with unresectable advanced pancreatic cancer - a single-institution experience].
abstract: Pancreatic adenocarcinoma is one of the leading causes of cancer deaths in Japan. Erlotinib plus gemcitabine( GEM) combination therapy provided significant improvements in the overall and progression-free survival in a phase III trial in Canada and a phase II trial in Japan. As a result, this combination therapy was approved for use in Japan. We evaluated the efficacy of erlotinib plus GEM in patients with unresectable pancreatic cancer. GEM at a dose of 1,000 mg/m2 was administered on days 1, 8, and 15 in a 4-week cycle. Erlotinib was taken orally at 100 mg/day until disease progression or unmanageable toxicity. Between October 2011 and April 2013, 9 patients were enrolled. The mean age was 62.3 years (range, 48-70 years), and 66.7% of patients were men. Eight patients had no prior therapy. All patients had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0. Eight patients had metastatic and 1 had locally advanced disease. Five patients had a history of smoking. The median duration of erlotinib administration was 133 days, and the median dose intensity was 100 mg/day, with the majority of patients( 88.9%) receiving 100% of the relative dose intensity. The median duration of GEM treatment was 5 cycles, and its median dose intensity was 890 mg/m2/week, with approximately half of the patients (66.7%) receiving >85% of the relative dose intensity. The most frequently reported adverse event was skin rash, which occurred in 44.4% of the patients. Other common non-hematological adverse events included facial edema, diarrhea, nausea, depilation, pruritus, and cholangitis. Most patients experienced some degree of hematological toxicity, with Grade 3 or 4 neutropenia, leukopenia, and anemia. Interstitial lung disease was not observed. The median overall survival was 7.63 months, and the 1-year survival rate was 15%. The median progression-free survival was 5.60 months. The overall response rate was 11.1%,and the disease control rate was 88.9% [complete response (CR), n =0; partial response( PR), n=1; stable disease( SD), n=7]. In conclusion, erlotinib plus GEM combination therapy is well tolerated and associated with efficacy and survival outcomes.
authors.affiliation: Dept. of Surgery, Kansai Rosai Hospital.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Takeda
authors.forename: Shin
authors.initials: S
authors.lastname: Nakahira
authors.forename: Yoshiteru
authors.initials: Y
authors.lastname: Katsura
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Kagawa
authors.forename: Masatsugu
authors.initials: M
authors.lastname: Okishiro
authors.forename: Atsushi
authors.initials: A
authors.lastname: Takeno
authors.forename: Hideki
authors.initials: H
authors.lastname: Sakisaka
authors.forename: Rei
authors.initials: R
authors.lastname: Suzuki
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Taniguchi
authors.forename: Chiyomi
authors.initials: C
authors.lastname: Egawa
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kato
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Tamura
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011799:Quinazolines / Q000008:administration & dosage; D000093542:Gemcitabine
chemical_list: D011799:Quinazolines; D003841:Deoxycytidine; D000069347:Erlotinib Hydrochloride; D000093542:Gemcitabine