Table 1 Comparative table of randomized controlled trials assessing the effect of heparin on the survival of patients with cancer
Study | Methods* | Intervention† | Participants‡ | Outcome assessment§ | Notes |
|---|---|---|---|---|---|
Lebeau 1994 | AC: adequate Blinded: outcome assessors, data analyst ITT analysis: yes Study stopped early: no | UFH (prophylactic dose) vs. no intervention for 5 weeks; in combination with chemotherapy | Small cell lung cancer both limited and extensive; 78% had Karnofsky > 80; 277 randomized and 277 followed up (100%); 85% older than 50 | Outcomes: mortality (at 12, 24, and 36 months) | Funding: None; maximum follow up: 84 months |
Kakkar 2004 (FAMOUS trial) | AC: adequate Blinded: patients, care givers ITT analysis: yes Study stopped early: no | LMWH (Dalteparin; prophylactic dose) vs. placebo for 12 months; no restriction on concomitant chemotherapy or radiotherapy | Different types of with advanced stage III or IV malignant disease of the breast, lung, gastrointestinal tract, pancreas, liver, genitourinary tract, ovary, or uterus; minimum life expectancy 3 months; 385 randomized, 374 followed up (97%); no withdrawal from treatment; median age 61 IQR [53–68] | Outcomes: mortality (at 12, 24, and 36 months), PE, DVT, major bleeding, and minor bleeding Screening testing for DVT/PE: None Diagnostic testing for DVT/PE: not reported | Funding: Pharmacia Corp, NY; maximum follow up: 77 months |
Klerk 2005 (MALT trial) | AC: adequate Blinded: patients, care givers, outcome assessors ITT analysis: yes Study stopped early: no | LMWH (Nadroparin) vs. placebo for 6 weeks; 2 weeks therapeutic dose then 4 weeks prophylactic dose; no concomitant chemotherapy or radiotherapy | Different types of solid malignant tumours "that could not be treated curatively" including: colorectal, breast, lung, gastric, oesophageal, liver, gallbladder, Katskin, prostate, pancreatic, cervical, urothelial, renal, ovarian, melanoma, endomaterial and other cancers; minimum life expectancy 1 month, stratified according to life expectancy (< or > 6 months); 302 patients randomized, 302 followed up (100%); median age 64 | Outcomes: mortality (at 6, 12, and 24 months), major bleeding, and minor bleeding | Funding: Sanofi provided study medication; maximum follow up: 84 months |
Altinbas 2004 | AC: not reported Blinded:outcome assessors ITT analysis: yes Study stopped early: no | LMWH (Dalteparin; prophylactic dose) vs. placebo for 18 weeks or less if disease progressed; in combination with chemotherapy | Small cell lung cancer both limited and extensive, ECOG state < 3; 84 patients randomized, 84 patients followed up (100%); median age 58 | Outcomes: mortality (at 12 and 24 months), DVT, and minor bleeding Screening and diagnostic testing for DVT: not reported | Funding: not reported; maximum follow up: 33 months |
Sideras 2006 | AC: adequate Blinded: patients, care givers, outcome assessors (1st 37% of randomized patients) ITT analysis: no Study stopped early for insufficient accrual | LMWH (Dalteparin; prophylactic dose) for unclear duration vs. placebo or no intervention | Different types of advanced cancer with minimum life expectancy 12 weeks; ECOG state 0–2; 141 randomized, 138 followed up (98%); no withdrawal from treatment; median age 67 | Outcomes: mortality (at 12, 24, and 36 months), VTE, and major bleeding. Screening testing for DVT/PE: None Diagnostic testing for DVT: decided by the primary clinician | Funding: governmentally funded, pharmaceutical company supplied drug and placebo; maximum follow up: 24 months |