A phase II trial evaluating capecitabine and irinotecan as second line treatment in patients with oesophago-gastric cancer who have progressed on, or within 3 months of platinum-based chemotherapy.
BACKGROUND
There is no standard second line therapy for relapsed oesophago-gastric (O-G) cancer.


METHODS
We recruited 29 eligible patients with relapsed O-G cancer who had progressed during or within 3 months of prior chemotherapy to assess the efficacy and toxicity of capecitabine [2,000 mg/(m(2) day) on days 1-14] and irinotecan (250 mg/m(2)) given every 3 weeks.


RESULTS
Five patients (17%) demonstrated objective response, while a further seven patients (24%) achieved disease stabilisation. Median progression-free survival and overall survival were 3.1 months (95% CI = 2.2-4.1 months) and 6.5 months (95%CI = 6-7.1 months), respectively. Among symptomatic patients, palliation of tumour-related symptoms included resolution of reflux (5/12 pts), dysphagia (3/9 pts) and weight loss (4/9 pts), improvements in anorexia (4/10 pts), nausea (3/4 pts), vomiting (4/6 pts) and pain (4/16 pts). Grade 3-4 toxicities were diarrhoea (15%), nausea and vomiting (7%), lethargy (31%), neutropenia (31%), anemia (14%) and thrombocytopenia (7%).


CONCLUSIONS
Capecitabine and irinotecan has anti-tumour activity as second line treatment for relapsed O-G cancer, and provides an important improvement in disease related symptoms.
Leary
Alexandra
A
Department of Medicine, Royal Marsden Hospital, Sutton, London, Surrey, UK. alexandra.leary@icr.ac.uk
Assersohn
L
L
Cunningham
D
D
Norman
A R
AR
Chong
G
G
Brown
G
G
Ross
P J
PJ
Costello
C
C
Higgins
L
L
Oates
J
J
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000503:physiopathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000503:physiopathology; D018450:Disease Progression; D018572:Disease-Free Survival; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D004943:Esophagogastric Junction / Q000187:drug effects / Q000503:physiopathology; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
D000077146:Irinotecan; D002166:Camptothecin