Table. Overview of randomized phase III studies of adjuvant cisplatin based chemotherapy versus observation in non-small cell lung cancer.
Study | Tumor stage | No of patients | Chemotherapeutic regimen/No of cycles | Median follow-up in months | Median survival in months: chemotherapy versus observation | 5 year survival rate: chemotherapy versus observation |
ALPI (9) | p I–IIIA | 1209 | Cisplatin + mitomycin C + vindesine; 3 cycles | 64.5 | 55.2 vs. 48 p = 0.6 | No data |
BLT (10) | p I–III | 381 | Cisplatin + mitomycin C + ifosfamide or Cisplatin + mitomycin C + vinblastine or Cisplatin + vindesine or Cisplatin + vinorelbine; 3 cycles | 34.6 | 33.9 vs. 32.6 p = 0.9 | No data |
IALT (11) | p I–III | 1867 | Cisplatin + etoposide or Cisplatin + vinorelbine or Cisplatin + vinblastine or Cisplatin + vindesine; 3–4 cycles | 56 | No data | 44.5 % vs. 40.4 % p < 0.03 |
Intergroup JBR.10 of NCIC (12) | p IB–IIB (without T3NOMO) | 482 | Cisplatin + vinorelbine; 4 cycles | 62 | 94 vs. 63 p = 0.009 | 69 % vs. 54 % p = 0.03 |
ANITA (14) | p IB–IIIA | 840 | Cisplatin + vinorelbine; 4 cycles | > 70 | 65.7 vs. 43.7 p = 0.02 | 51 % vs. 43 % p = 0.02 |
The pooled analysis (LACE, lung adjuvant cisplatin evaluation) of the data from the 5 studies using cisplatin based chemotherapy (BLT, ALPI, IALT, NCIC JBR.10, ANITA) including 4584 patients showed an absolute 5 year benefit of 4.2% for the patients treated with cisplatin (15).