Randomized trial of neoadjuvant chemotherapy followed by radical surgery in locally advanced squamous cell cervical carcinoma (LASCCC). Comparison of paclitaxel, cisplatin (TP), versus paclitaxel, ifosfamide, cisplatin (TIP): The SNAP-02 Italian collaborative study

2005 ◽  
Vol 23 (16_suppl) ◽  
pp. 5026-5026 ◽  
Author(s):  
R. Fossati ◽  
A. Buda ◽  
E. Rulli ◽  
F. Landoni ◽  
A. Lissoni ◽  
...  
2005 ◽  
Vol 23 (18) ◽  
pp. 4137-4145 ◽  
Author(s):  
Alessandro Buda ◽  
Roldano Fossati ◽  
Nicoletta Colombo ◽  
Francesca Fei ◽  
Irene Floriani ◽  
...  

Purpose Neoadjuvant chemotherapy may represent an alternative to irradiation in locally advanced squamous cell cervical cancer. Aims of this study were to compare a three-drug (paclitaxel, ifosfamide, and cisplatin [TIP]) with a two-drug (ifosfamide and cisplatin [IP]) regimen and to assess the prognostic value of pathologic response on survival. Patients and Methods Patients (n = 219) were randomly assigned to ifosfamide 5 g/m2 during 24 hours plus cisplatin 75 mg/m2, or paclitaxel 175 mg/m2 plus ifosfamide 5 g/m2 during 24 hours and cisplatin 75 mg/m2 every 3 weeks for three courses. Results Grades 3 to 4 neutropenia, anemia, and thrombocytopenia were more frequent with TIP. We recorded four deaths related to toxicity. The optimal pathologic response (OPT) rate (residual disease < 3 mm stromal invasion) was higher with TIP than with IP (48% v 23%; odds ratio, 3.22; 95% CI, 1.69 to 5.88; P = .0003). At a median follow-up of 43.4 months, 79 women experienced disease progression or died (46 in the IP arm, 33 in the TIP arm). Patients receiving TIP experienced a treatment failure rate 25% less than those receiving IP, but this difference was not statistically significant (hazard ratio [HR], 0.75; 95% CI, 0.48 to 1.17; P = .20). Sixty-one patients died (37 in the IP arm, 24 in the TIP arm), and the HR of death was in favor of TIP, although not significantly (HR, 0.66; 95% CI, 0.39 to 1.10; P = .11). In patients assessable for response (n = 189), the average death rates were higher in the group that did not achieve OPT (HR, 5.88; 95% CI, 2.50 to 13.84; P < .0001). Conclusion The TIP regimen is associated with a higher response rate than the IP regimen, without a statistically significant effect on overall survival. OPT was a prognostic factor for survival.


1991 ◽  
Vol 41 (3) ◽  
pp. 212-216 ◽  
Author(s):  
Pierluigi Benedetti Panici ◽  
Stefano Greggi ◽  
Giovanni Scambia ◽  
Guglielmo Ragusa ◽  
Gabriela Baiocchi ◽  
...  

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e16532-e16532
Author(s):  
Giuseppa Scandurra ◽  
Giuseppe Scibilia ◽  
Giuseppe Luigi Banna ◽  
Helga Maria Alessandra Lipari ◽  
Gabriella D'Agata ◽  
...  

e16532 Background: The management of locally advanced squamous cell cervical carcinoma includes chemoradiotherapy or neoadjuvant cisplatin based chemotherapy followed by surgery, that may offer specific advantages a better potential activity. Porpouse: To evaluate efficacy and safety of TIP neoadjuvant chemoregimen in patiens affects by local advanced squamous cell cervical carcinoma. Methods: July 1997 - December 2011 were treated at our institution 165 patients with locally advanced squamous cell cervical carcinoma of whom 143 are evaluable. Regimen: Ifosfamide 5000 mg/mq ev day 1 iv in 24 h ; Mesna 5000 mg/mq ev day 1 iv in 24 h ; Paclitaxel 175 mg/mq ev day 2; Cisplatin 75 mg/mq ev day 2; every 3 weeks for a total of three courses. Tumor extension was assessed clinically and by abdominal MRI, PET WB and 3D ultrasound at baseline and after three courses.The operable patients after TIP chemoterapy underwent radical hysterectomy and pelvic lymphadenectomy. The median age 53 ( range 24-79 yrs), clinical FIGO stage Ib 2 2 pts(1%) , IIb 59 pts(41%), IIb bulky 68 pts (48%), III-IV 14 pts (10%), histological subtype SCC 138 pts (96%) and adenocarcinoma 5 pts ( 4%). Results: After neoadjuvant chemiotherapy 132 pts (92%) underwent surgery. Post-chemotherapy pathological response was pCR 25 pts (19%), PR1 16 pts (12%), PR2 80 pts (61%), SD 10 pts (7%), PD 1 pt (1%). Median numbers of courses of TIP administrated was 3 ( range 1-3). Treatments was delay or withdrawal in 22 pts ( 16%). Treament limiting toxicities were, Neutropenia 11 pts (52%), Anemia 10 pts (45%),Thrombocytopenia 7 pts (33 %), Renal failure 3 pts (14 %), Allergic reaction 3 pts (14%), Vomiting 3 pts (14%), Febrile neutropenia 2 pts (10%), Hypopotassiemia1 pt (5%), Atrial fibrillation 1pt( 5%), Pneumonia 1 pt (5%). Conclusions: In our experience neoadjuvant TIP was feasible, effective with 92% resection rate and active in an older and higher stage disease enriched series than reported in previous clinical trials.


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