title: A pilot study of nimotuzumab plus single agent chemotherapy as second- or third-line treatment or more in patients with recurrent, persistent or metastatic cervical cancer.
abstract: Nimotuzumab is a humanized IgG1 monoclonal antibody against the EGFR extracellular domain that has been evaluated in solid tumors as a single agent or in combination with chemotherapy and radiation. Cervical cancer patients who are refractory or progressive to first-line chemotherapy have a dismal prognosis, and no second- or third-line chemotherapy is considered standard. This pilot trial aimed to evaluate the efficacy and safety of nimotuzumab in 17 patients with pre-treated advanced refractory or progressive cervical cancer. Nimotuzumab was administered weekly at 200 mg/m(2) as single agent for 4 weeks (induction phase), then concurrent with 6 21-day cycles of gemcitabine (800 mg/m(2)) or cisplatin (50 mg/m(2)) for 18 weeks (concurrent phase) and then once every 2 weeks (maintenance phase). Nimotuzumab could be continued beyond disease progression. Seventeen patients were accrued and evaluated for safety and efficacy. The median number of nimotuzumab applications was 20 (5-96). The median number of chemotherapy cycles administered was 6 (1-6). No toxicity occurred during induction and maintenance phases (single agent nimotuzumab). In the concurrent phase, grade 3 toxicity events observed were leucopenia, anemia and diarrhea in 11.7%, 5.8% and 11.7% respectively. No complete or partial responses were observed. The stable disease (SD) rate was 35%. The median PFS and OS rates were 163 days (95% CI, 104 to 222), and 299 days (95% IC, 177 to 421) respectively. Nimotuzumab is well tolerated and may have a role in the treatment of advanced cervical cancer.
authors: a División de Investigación Clínica; Instituto Nacional de Cancerología , México City , México.
authors: Lucely
authors: L
authors: Cetina
authors: Tania
authors: T
authors: Crombet
authors: Roberto
authors: R
authors: Jiménez-Lima
authors: Sergio
authors: S
authors: Zapata
authors: Mayra
authors: M
authors: Ramos
authors: Sandra
authors: S
authors: Avila
authors: Jaime
authors: J
authors: Coronel
authors: Eduardo
authors: E
authors: Charco
authors: Rafael
authors: R
authors: Bojalil
authors: Horacio
authors: H
authors: Astudillo
authors: Blanca
authors: B
authors: Bazán
authors: Alfonso
authors: A
authors: Dueñas-González
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011379:Prognosis; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
chemical_list: D061067:Antibodies, Monoclonal, Humanized; C501466:nimotuzumab
keywords: ALT, Alanine Aminotransferase; AST, Aspartate Aminotransferase; CTCAE, Common Terminology Criteria for Adverse Events; ECOG, Eastern Cooperative Oncology Group; EGFR; EGFR, Epidermal Growth Factor Receptor; G-CSF, Granulocyte-Colony Stimulating Factor; RECIST, Response and Evaluation Criteria In Solid Tumors; advanced cervical cancer; monoclonal antibody; nimotuzumab; pilot study