Sundstrom 2002.

Methods	STUDY DESIGN: Parallel study LOCATION, NUMBER OF CENTRES: Norway, multicentric DURATION OF STUDY: January 1989 to August 1994 CONCEALMENT OF ALLOCATION:D DESCRIBED AS RANDOMISED: Yes DESCRIBED AS DOUBLE BLIND: No METHOD OF RANDOMISATION WELL‐DESCRIBED/APPROPRIATE: Adequate METHOD OF BLINDING WELL‐DESCRIBED/APPROPRIATE: Not described DESCRIPTION OF WITHDRAWALS/DROP‐OUTS: Adequate GRADE ASSESSMENT QUALITY RATING: High TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT
Participants	ELIGIBILITY INCLUSION CRITERIA: Histologically/cytologically confirmed SCLC; age of 18 to 75 years; and Eastern Cooperative Oncology Group (ECOG) performance status <= 2; adequate bone marrow and renal function (WBC count >= 3000/µL, platelet count >= 125,000/ µL, serum creatinine level < 125 µmol/L); no serious cardiovascular disease, and no previous or other concomitant malignant disease with the exception of basal cell carcinoma or in situ carcinoma of the cervix. Patients with evidence of brain metastases were eligible. EXCLUSION CRITERIA: N SCREENED: 440 N RANDOMISED: 436 (EP ‐ 218; CEV ‐ 218) N COMPLETED: ASSESS STAGE: Yes (N LIMITED): 214 (N EXTENSIVE): 222 M: 281 F: 155 AGE: median ‐ 64, range (EP ‐ 43 to 75; CEV ‐ 44 to 75)
Interventions	TYPE: Chemotherapy REGIMENS: EP ‐ etoposide 100 mg/m2 followed by cisplatin 75 mg/m2, both administered intravenously (IV) on day 1. Daily oral etoposide 200 mg/m2 was given on days 2 to 4 (on an empty stomach). Standard prehydration and posthydration procedures were followed in conjunction with cisplatin administration. CEV ‐ epirubicin 50 mg/m2, cyclophosphamide 1000 mg/m2, and vincristine 2 mg, all IV on day 1. For both, chemotherapy was administered every 3 weeks to a maximum of 5 courses. Before the third course, all patients were evaluated for a response. CO‐INTERVENTIONS: Patients who achieved complete remission during the treatment period received prophylactic cranial irradiation. ED ‐ SCLC patients did not receive radiotherapy as part of routine therapy. But chest or cranial irradiation was optional if severe symptoms could not be palliated by chemotherapy.
Outcomes	OUTCOMES MEASURED: Tumour response (according to World Health Organization response criteria) Relapse pattern and palliative treatment Survival Toxicity Quality of life FOLLOW UP ASSESSMENT POINTS: OUTCOMES INCLUDED IN ANALYSES: Tumour response (according to World Health Organization response criteria) Relapse pattern and palliative treatment Survival Toxicity Quality of life
Notes
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	N/A
Blinding (performance bias and detection bias) Toxicity	Unclear risk	N/A
Blinding (performance bias and detection bias) Quality of Life	Unclear risk	Not reported
Incomplete outcome data (attrition bias) Survival	Low risk	Reasons for withdrawals, drop‐outs and exclusions reported
Incomplete outcome data (attrition bias) Tumour Response	Unclear risk	N/A
Incomplete outcome data (attrition bias) Toxicity	Unclear risk	N/A
Incomplete outcome data (attrition bias) Quality of Life	High risk	Data incomplete
Selective reporting (reporting bias)	Unclear risk	Insufficient information
Other bias	Low risk	Adequate