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: Lucely Cetina, Tania Crombet, Roberto Jiménez-Lima, Sergio Zapata, Mayra Ramos, Sandra Avila, Jaime Coronel, Eduardo Charco, Rafael Bojalil, Horacio Astudillo, Blanca Bazán, Alfonso Dueñas-González
• Journal: Cancer biology & therapy (Cancer Biol Ther) Vol. 16 Issue 5 Pg. 684-9 ( 2015) ISSN: 1555-8576 [Electronic] United States
• PMID: 25802932 (Publication Type: Journal Article)

Chemical References

• Antibodies, Monoclonal, Humanized
• nimotuzumab

Topics

• Adult
• Aged
• Antibodies, Monoclonal, Humanized (administration & dosage, therapeutic use)
• Disease-Free Survival
• Female
• Humans
• Male
• Middle Aged
• Pilot Projects
• Prognosis
• Uterine Cervical Neoplasms (drug therapy)