Clinical Study On Treatment Of Recurrent Cervical Cancer With TGOP

Objective:Retrospective analysis on the efficacy and safety of tegafur,gimeracil and oteracil potassium(TGOP)alone or in combination with other drugs in treating recurrent cervical cancer.Methods: Thirty-two patients with recurrent cervical cancer were included,including twelve ones treated with a combination of TGOP and platinum drugs and twenty ones treated with TGOP alone.The dosage regimen of TGOP and platinum drugs combined was: nedaplatin 80-100mg/m2 d1 or carboplatin(GFR+25)* AUC(5)d1 or cisplatin 70mg/m2 d1-3;TGOP 80mg/m2 d1-d14,repeated once every 3 weeks;the dosage regimen of TGOP alone was: TGOP 80mg/m2 d1-d14,repeated once every 3 weeks.The primary endpoints were overall response rate(CR+PR),disease control rate(CR+PR+SD),progression free survival(PFS),and overall survival(OS)in all patients and each regimen;the secondary endpoint was chemotherapy side effects,including: hematologic toxicity,gastrointestinal toxicity,liver and kidney damages,skin toxicity,and oral mucositis.The disease control rate was assessed with the Version 1.1Response Evaluation Criteria in Solid Tumors(RECIST v 1.1)after every 2-3 cycles of chemotherapy;the adverse events of chemotherapy were assessed with the Version 4.0Common Terminology Criteria for Adverse Events(CTCAE v 4.0).Results: The overall response rate of combined TGOP with platinum drugs and TGOP alone were 8.3% and 5%,respectively(P=1),The overall response rate was 6.25% for the two regimens.The overall disease control rate was 40.6% for the two regimens.The disease control rates of combined TGOP with platinum drugs and TGOP alone were 41.6% and 40%,respectively(P=0.607).The overall disease control rate was 40.6% for the two regimens;the median PFS was 5.6 months and 4.5 months,respectively(P=0.135),the median OS was 12.5 months and 11.3 months,respectively(P=0.237),the overall median PFS and the overall median OS were 5.5 months and 12.5 months for the two regimens.The most common Grade 3-4 adverse events were anemia 12.5%(Combined regimen:25%;single regimen:5%),leucopenia 9.4%(Combined regimen:16.7%;single regimen: 5%),nausea 9.4%(Combined regimen:16.7%;single regimen: 5%).Grade 0 adverse events were more common in the single dosage regimen than in the combination dosage regimen.However,Grade III+IV and Grade I-IV adverse events were less common in the former than in the latter.There were statistically significant differences in white blood cells,neutrophils,hemoglobin,platelets,nausea and vomiting,AST/ALT,and fatigue.There were no significant differences in hyperpigmentation,diarrhea and oral mucositis.Conclusion: The results of this study show that there is no statistically significant difference in the rate of overall response rate,disease control,progression-free survival,and overall survival between the the combination of TGOP with platinum drugs and the single dosage regimen of TGOP.The adverse effects of TGOP alone were significantly reduced when compared with those of the combination dosage regimen,and there were significant statistical differences between the two regimens.This study suggested similar effects of TGOP plus platinum and TGOP alone,but there was a significant difference in safety.It thus can be inferred that TGOP provides a adjuvant chemotherapy option for patients with recurrent cervical cancer and its toxic and side effects are tolerable...