Table 1. The survival gains, toxicity profiles and cost of three anticancer drugs with an OS of 6.5 months or less.
| Drug | Study name | Year of FDA approval |
Indication | Survival with the drug | Survival in control arm (control agent) | Gain in survival | SAE (drug) | SAE (control) | FAE (drug) | FAE (control) | Cost of 1 month treatment (WAC) | Reference (Pubmed ID) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Regorafenib | CORRECT | 2012 | Last line treatment of metastatic colorectal cancer | 6.4 | 5.0 (placebo) | 1.4 | 219/500 (43.8%) | 100/253 (39.5%) | 8/500 (1.6%) | 3/253 (1.2%) | $9919 | 23177514 |
| Ramucirumab | REGARD | 2014 | Second line treatment of metastatic gastric or gastro-oesophageal junction cancer | 5.2 | 3.8 (placebo) | 1.4 | NR | NR | 5/236 (2.1%) | 2/115 (1.7%) | $13,093 | 24094768 |
| Liposomal Irinotecan* | NAPOLI-1 | 2015 | Second line treatment of metastatic pancreatic cancer | 6.1 | 4.2 (fluorouracil + folinic acid) | 1.9 | 146/264 (55.3%) | 60/134 (44.8%) | 5/264 (1.9%) | 0/134 (0%) | $9720 | 26615328 |
Common adverse events (with incidence >10% in clinical trials) with the three drugs that provide a survival of 6 months (survival benefit of <2months).
1. Regorafenib: Fatigue, hand–foot skin reaction, diarrhoea, anorexia, hypertension, oral mucositis, rashes, nausea, weight loss, fever, thrombocytopenia.
2. Ramucirumab: Fatigue, abdominal pain, loss of appetite, vomiting, constipation, anaemia, dysphagia.
3. Nanoliposomal Irinotecan: Diarrhoea, vomiting, nausea, loss of appetite, fatigue, neutropenia, aneamia, hypokalaemia
there were three arms in NAPOLI-1 trial: liposomal irionotecan alone (1), liposomal irinotecan +fluorouracil +folinic acid (2) and fluorouracil +folinic acid (3). Only arm 2 was shown superior and survival data corresponds to comparison between arms 2 and 3. For safety data, arms 1 and 2 are combined
WAC = wholesale acquisition costs. These were obtained from the list available at https://www.mskcc.org/sites/default/files/node/25097/documents/120915-drug-costs-table.pdf
For liposomal irinotecan, the WAC was calculated from the information available at: http://secure.medicalletter.org/w1496e
NR = not reported