Table 2.
Incidence of oxaliplatin-induced peripheral neuropathy in prospective clinical studies
| Study | Design | Pts (N) |
Cancer type(s) | Clinical features of oxaliplatin-induced peripheral neuropathy | ||
|---|---|---|---|---|---|---|
| Assessment methods | Duration of follow-up | Incidence | ||||
| Giacchetti (2000)132 | Phase III | 100 | CRC | Specific neuropathy scale | Median follow-up 19 months | Grades 1-2: 45%; grades 3-4: 10% |
| de Gramont (2000)133 | Phase III | 209 | CRC | NCI-CTC | Median follow-up 8 months | Grades 1-2: 50%; grades 3-4: 18% |
| Rothenberg (2003)134 | Phase III | 303 | CRC | NCI-CTC-derived scale | Maximum follow-up 14 months | Grades 1-2: 48-49%; grades 3-4: 2.−3% |
| André (2004)135 | Phase III | 1108 | CRC | NCI-CTC | Median follow-up 38 months | Grades 1-2: 80%; grade 3: 12% |
| Tournigand (2006)105 | Phase III | 612 | CRC | NCI-CTC | Median follow-up 31 months | Grades 1-2: 71-78%; grades 3-4: 13-18% |
| Land (2007)136 | Phase III | 189 | CRC | NCI-CTC, FACT/GOG-Ntx, NCI-Sanofi | Up to 18 months after CMT completion | Grades 1-2: 61-68%; grades 3-4: 3% |
| Al-Batran (2008)123 | Phase III | 112 | GE | NCI-CTC, oxaliplatin scale | Median follow-up 6 months | Grades 1-2: 49%; grades 3-4: 14% |
| Cassidy (2008)137 | Phase III | 1304 | CRC | NCI-CTC | Median follow-up 30 months | Grades 1-2: 16%; grades 3-4: 4% |
| Cunningham (2008)138 | Phase III | 452 | GE | NCI-CTC | Median follow-up 17 months | Grades 1-2: 75%; grades 3-4: 7% |
| Allegra (2009)139 | Phase III | 2647 | CRC | NCI-CTC | Up to 1 year after CMT completion | Grade 2: 29-33%; grade 3: 14-16% |
| Poplin (2009)140 | Phase III | 272 | Pancreas | NCI-CTC | NR | Grade 3: 10% |
| Qvortrup (2010)141 | Phase III | 139 | CRC | NCI-CTC | Median follow-up 14 months | Grade 2: 27-42%; grade 3: 16-19% |
| Argyriou (2012)142 | Prospective | 150 | CRC | NCI-CTC, NCS, TNS | Up to 1 month after CMT completion | Grades 1-2: 45-73%; grade 3: 10-18% |
| Conroy (2014)127 | Phase II/III | 131 | Oesophagus | NCI-CTCAE | Median follow-up 25.3 months | Grades 1-2: 47%; grades 3-4: 0% |
| Yamada (2015)128 | Phase III | 339 | Gastric | NCI-CTCAE | Median follow-up 25.9 months | Grades 3-4: 5%, any grade: 86% |
| Bando (2016)129 | Phase III | 343 | Gastric | NCI-CTCAE | Median follow-up 13.5 months | Grades 3-4: 4.5-5.3% |
| Lonardi (2016)143 | Phase III | 3759 | CRC | NCI-CTC | Maximum follow-up 3 years | Grade 2: 8-23%; grade 3: 1-8% |
| Ramaswamy (2017)131 | Prospective | 163 | Gallbladder | NR | NR | Grades 2-3: 9%, |
| Iveson (2018)144 | Phase III | 6022 | CRC | FACT/GOG-Ntx | Maximum follow-up 8 years | Grades 1-2: 77-87%; grades 3-4: 16-18% |
CMT: chemotherapy; CRC: colorectal cancer; FACT/GOG-Ntx: Functional Assessment of Cancer Therapy Scale/Gynecologic Oncology Group-Neurotoxicity scale; GE: gastroesophageal; NCI-CTC, National Cancer Institute Common Toxicity Criteria; NCI-CTCAE: National Cancer Institute Common Terminology Criteria for Adverse Events; NCI-Sanofi: oxaliplatin Sanofi questionnaire; NCS: Nerve Conduction Study; NR: not reported; TNS: Total Neuropathy Score.