Sculier 1990.
| Methods | STUDY DESIGN: Parallel study
LOCATION, NUMBER OF CENTRES:
DURATION OF STUDY:
CONCEALMENT OF ALLOCATION: D
DESCRIBED AS RANDOMISED: Yes
DESCRIBED AS DOUBLE BLIND: No
METHOD OF RANDOMISATION WELL‐DESCRIBED/APPROPRIATE: Not described
METHOD OF BLINDING WELL‐DESCRIBED/APPROPRIATE: Not described
DESCRIPTION OF WITHDRAWALS/DROP‐OUTS: Yes GRADE ASSESSMENT QUALITY RATING: High TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT |
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| Participants | ELIGIBILITY
INCLUSION CRITERIA: Patients with pathologically proven SCLC (histology was checked by 2 independent pathologists according to the WHO classification) had to have received no prior therapy (radiotherapy, chemotherapy or surgery), have an evaluable or measurable lesion, a Kamofsky performance status of at least 50, no history of prior malignant tumour except non‐melanoma skin cancer or in situ carcinoma of the cervix, and no demonstrated brain metastasis. In addition, they had to have adequate haematological (white blood cells >= 3000/mm3 and platelets >= 100,000/mm3), renal (serum creatinine < 1.5 mg/dl) and hepatic (serum bilirubin < 1.5 mg/dl) functions, be aged <= 75 years, have no uncontrolled infectious disease, be accessible for follow up and provide informed consent. EXCLUSION CRITERIA: N SCREENED: 221 (201 eligible) N RANDOMISED: 201 (CEV ‐ 95; EV ‐ 106) N COMPLETED: ASSESS STAGE: Yes (N LIMITED): 99 (N EXTENSIVE): 102 M: 181 F: 20 AGE: median: CEV ‐ 61; EV ‐ 62 (range: CEV ‐ 37 to 75; EV ‐ 35 to 74) |
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| Interventions | TYPE: Chemotherapy
REGIMENS:
CEV ‐ cisplatin 60 mg/m2 on day 1; etoposide 120 mg/m2 on days 1, 2 and 3; vindesine 3 mg/m2 on day 1
EV ‐ etoposide 120 mg/m2 on days 1, 2 and 3; vindesine 3 mg/m2 on day 1 All drugs were IV administered. Cisplatin was given by IV drip over 15 minutes, after prehydration with 1000 ml of 5% dextrose in half normal saline for 1½ hours. Another litre of the same solution was then infused over 2 hours. Patients received 40 mg IV of furosemide during prehydration and immediately after cisplatin administration. Vindesine was given by IV bolus also after the cisplatin administration and prior to the infusion of etoposide. Etoposide was diluted in 500 ml of saline and given over 1 hour. Administration of high doses of metoclopamide was recommended for control of emesis. Courses were repeated every 3 weeks, according to haematologic status, for a total of 8 courses. |
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| Outcomes | OUTCOMES MEASURED: Tumour response Toxicity Survival FOLLOW UP ASSESSMENT POINTS: OUTCOMES INCLUDED IN ANALYSES: Tumour response Toxicity Survival | |
| Notes | Other: 20 patients were ineligible because of having: non‐small cell lung cancer (6), brain metastases initially (5), no brain CT scan at initial workup (5), a history of prior malignant disease (2), thrombocytopenia (1), an incomplete initial workup (1). Of the 201 eligible patients, 18 were not evaluable for response to chemotherapy for the following reasons: loss to follow up (4), treatment refusal (2), workup refusal at evaluation (1), death prior to receiving chemotherapy (1), drug dosage violation (2), and early death considered not due to SCLC or toxicity (8). | |
| 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 | Not reported |
| Blinding (performance bias and detection bias) Quality of Life | Unclear risk | N/A |
| Incomplete outcome data (attrition bias) Survival | Low risk | Reasons for withdrawals, drop‐outs and exclusions reported |
| Incomplete outcome data (attrition bias) Tumour Response | Low risk | Reasons for withdrawals, drop‐outs and exclusions reported |
| Incomplete outcome data (attrition bias) Toxicity | Low risk | Reasons for withdrawals, drop‐outs and exclusions reported |
| Incomplete outcome data (attrition bias) Quality of Life | Unclear risk | N/A |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information |
| Other bias | Low risk | Adequate |