Patient-reported outcomes of patients with advanced biliary tract cancers receiving gemcitabine plus capecitabine: a multicenter, phase II trial of the Swiss Group for Clinical Cancer Research.
OBJECTIVE
To evaluate the effects of palliative chemotherapy with gemcitabine plus capecitabine (GemCap) on patient-reported outcomes measured using clinical benefit response (CBR) and quality-of-life (QOL) measures in patients with advanced biliary tract cancer.


METHODS
Patients had to manifest symptoms of advanced biliary tract cancer and have at least one of the following: impaired Karnofsky performance score (60 to 80), average analgesic consumption >or= 10 mg of morphine equivalents per day, and average pain intensity score of >or= 20 mm out of 100 mm. Treatment consisted of oral capecitabine 650 mg/m(2) twice daily on days 1 through 14 plus gemcitabine 1,000 mg/m(2) as a 30-minute infusion on days 1 and 8 every 3 weeks until progression. The primary end point was the number of patients categorized as having a CBR or stable CBR (SCBR) during the first three treatment cycles.


RESULTS
Forty-four patients were enrolled (bile duct cancer, n = 36; gallbladder cancers, n = 8). The main grade 3 or 4 adverse events included hematologic toxicity and fatigue. After three cycles, 36% of patients achieved a CBR, and 34% achieved an SCBR. Over the full course of treatment, 57% of patients achieved a CBR, and 18% achieved an SCBR. Improved QOL was observed in patients with a CBR or SCBR. The objective response rate was 25%. Median time to progression and overall survival times were 7.2 months and 13.2 months, respectively.


CONCLUSIONS
Chemotherapy with GemCap is well tolerated and effective and leads to a high CBR rate. Patient-reported outcomes are useful for evaluating the effects of palliative chemotherapy in patients with biliary tract cancer.
Koeberle
Dieter
D
Department of Internal Medicine, Division Oncology/Hematology, Kantonsspital St Gallen, CH-9007 St Gallen, Switzerland. dieter.koeberle@kssg.ch
Saletti
Piercarlo
P
Borner
Markus
M
Gerber
Daniela
D
Dietrich
Daniel
D
Caspar
Clemens B
CB
Mingrone
Walter
W
Beretta
Kurt
K
Strasser
Florian
F
Ruhstaller
Thomas
T
Mora
Oreste
O
Herrmann
Richard
R
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D007262:Infusions, Intravenous; D017567:Karnofsky Performance Status; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D010147:Pain Measurement; D010166:Palliative Care; D011788:Quality of Life; D013557:Switzerland; D013997:Time Factors; D016896:Treatment Outcome; D000093542:Gemcitabine
D000700:Analgesics; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine