Scheithauer 1993.
| Methods | RCT: To compare the length of survival and QoL in previously untreated patients with histologically confirmed, measurable colorectal cancer that was recurrent/metastatic Duration: between April 1988 and September 1989 40 patients accrued to the study Patients in both arms received SC Journal: British Medical Journal 1993 |
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| Participants | Participants: 40 previously untreated patients with histologically confirmed, measurable colorectal cancer (inoperable adenocarcinoma of the colon/rectum) that was locally recurrent or metastatic. Life expectancy over two months Median Age (years and range): combination chemotherapy group + SC: 63 (28 to 75) No chemotherapy (BSC) group: 69 (45 to 75). All patients: 66 (28 to 75) Gender: Male/Female ratio Combination chemotherapy group: 10/14 No chemotherapy (BSC) group: 7/5 All patients 17/19 Performance status: ECOG PS of less than or equal to 3. |
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| Interventions | Total N = 36 T1: Combination chemotherapy (5‐fluorouracil, leucovorin and cisplatin) + SC (n = 24). Chemotherapy consisted of four week cycles of intravenous leucovorin (200 mg/m2/day) followed by 5‐FU (550 mg/m2/day) and cisplatin (20 mg/m2/day), each drug being given on the first four days of the cycle. versus T2: No Chemotherapy (SC) (n = 12) All patients (n = 36). |
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| Outcomes | Length of survival and QOL score with an optimized functional living index‐cancer scale (FLIC) T1: Overall survival was significantly longer T1: 11.0 months versus T2: 5.0 months; (P = 0.006). QoL: T1 versus T2: There was no significant difference between the two groups in global/subgroup QoL scores. In patients with abnormal scores before treatment, QoL seemed better in the chemotherapy arm. Quality of life in patients with metastatic colorectal cancer by treatment group. Overall response rate: T1 12/18 (67%) T2 5/8 (62%). Median (range) duration of response (months) T1 7 (4 to 18) T2 6 (4 to 9). |
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| Notes | Authors conclusions: Chemotherapy regimen was an effective form of palliative treatment. Data indicate that chemotherapy with 5‐FU, leucovorin, and cisplatin improves QoL in symptomatic patients with metastatic colorectal cancer and prolongs survival, although the small numbers of patients reduces the strength of the results, they support previous indirect evidence of a beneficial effect of chemotherapy in this disease | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | D ‐ Not used |
GI: Gastrointestinal BSC: Best supportive care SC: Supportive Care ECOG: Eastern Cooperative Oncology Group KPS: Karnofsky Performance Status WHOI: World Health Organisation PS ‐ Performance status QoL ‐ Quality of life RCT: Randomised Controlled Trial 5‐FU: 5 Fluorouracil