Chahinian 1989.
| Methods | STUDY DESIGN: Parallel study
LOCATION, NUMBER OF CENTRES: 20 Cancer and Leukaemia Group B (CALGB) main member institutions
DURATION OF STUDY: February 1981 to May 1984
CONCEALMENT OF ALLOCATION: D
DESCRIBED AS RANDOMISED: Yes
DESCRIBED AS DOUBLE BLIND:
METHOD OF RANDOMISATION WELL‐DESCRIBED/APPROPRIATE: Not described
METHOD OF BLINDING WELL‐DESCRIBED/APPROPRIATE: Not described
DESCRIPTION OF WITHDRAWALS/DROP‐OUTS: Not described GRADE ASSESSMENT QUALITY RATING: Low TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT |
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| Participants | ELIGIBILITY
INCLUSION CRITERIA:
CALGB performance status of 0 to 3
Informed consent
One measurable tumour EXCLUSION CRITERIA: Prior chemotherapy Myocardial infarction within 6 months Cardiac failure Serious arrhythmia not directly attributable to metastatic small cell lung cancer Patients with any contraindications to the use of warfarin Patients already on warfarin N RANDOMISED: 294 ASSESS STAGE: Yes (N LIMITED): 0 (N EXTENSIVE): 294 M: 199 (MACC ‐ 62; MACC + W ‐ 70; MEPH/MACC ‐ 67) F: 95 (MACC ‐ 24; MACC + W ‐ 33; MEPH/MACC ‐ 38 AGE: |
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| Interventions | TYPE: Chemotherapy
REGIMENS:
MACC ‐ methotrexate (30 mg/m2 intravenously [IV]), doxorubicin (40mg/m2 IV), cyclophosphamide (400 mg/m2 IV) and lomustine (30 mg/m2 orally) given once every 3 weeks. Doxorubicin was discontinued after a total cumulative dose of 450 mg/m2 MACC + W ‐ methotrexate (30 mg/m2 intravenously [IV]), doxorubicin (40 mg/m2 IV), cyclophosphamide (400 mg/m2 IV), lomustine (30 mg/m2 orally) and warfarin sodium (single oral daily dose of 10 mg starting on day 1) given once every 3 weeks. Doxorubicin was discontinued after a total cumulative dose of 450 mg/m2. MEPH/MACC ‐ Mitomycin (7 mg/m2 IV on day 1), etoposide (40 mg/m2 IV on days 1 to 3), cisplatin (50 mg/m2 IV on day 1) and hexamethylmelamine (100 mg/m2 orally from day 3 to 17). This was the MEPH regimen. On day 35 (week 6) of each cycle, patients received MACC chemotherapy as described above. On day 56 (week 9), MEPH component was given again 3 weeks after MACC. The two regimens were alternated in this fashion (MEPH/MACC) CO‐INTERVENTIONS: Radiotherapy CLASSIFICATION OF INTERVENTION (ADJUVANT/NEO‐ADJUVANT/PALLIATIVE): Palliative |
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| Outcomes | OUTCOMES MEASURED:
Tumour response
Overall survival
Toxicity FOLLOW UP ASSESSMENT POINTS: OUTCOMES INCLUDED IN ANALYSES: Tumour response Overall survival |
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| Notes | Only data from arms MACC + W and MEPH/MACC were considered for this systematic review | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) Participants | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) Investigators | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) Survival | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) Tumour Response | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) Toxicity | Unclear risk | N/A |
| Blinding (performance bias and detection bias) Quality of Life | Unclear risk | N/A |
| Incomplete outcome data (attrition bias) Survival | Unclear risk | Reasons for withdrawals, drop‐outs and exclusions not reported |
| Incomplete outcome data (attrition bias) Tumour Response | Unclear risk | Reasons for withdrawals, drop‐outs and exclusions not reported |
| Incomplete outcome data (attrition bias) Toxicity | Unclear risk | N/A |
| Incomplete outcome data (attrition bias) Quality of Life | Unclear risk | N/A |
| Selective reporting (reporting bias) | Low risk | Adequate |
| Other bias | Low risk | Adequate |