TY - JOUR
T1 - Weekly topotecan and cisplatin (TOPOCIS) as neo-adjuvant chemotherapy for locally-advanced squamous cervical carcinoma
T2 - Results of a phase II multicentric study
AU - Zanaboni, F.
AU - Grijuela, B.
AU - Giudici, S.
AU - Cormio, G.
AU - Babilonti, L.
AU - Ghezzi, F.
AU - Giorda, G.
AU - Scambia, G.
AU - Franchi, M.
AU - Lorusso, M.
AU - Ditto, A.
AU - Lorusso, D.
AU - Raspagliesi, F.
PY - 2013/3
Y1 - 2013/3
N2 - Objectives: The aim of this phase II multicentric study was to evaluate the efficacy and toxicity of neo-adjuvant chemotherapy with weekly topotecan and cisplatin in locally-advanced squamous cervical cancer. Patients and methods: From November 2008 to January 2011, 92 patients met the inclusion criteria and were enrolled. Eligibility criteria were: squamous or adenosquamous cervical cancer; clinical stages IB2, IIA, IIB; Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2; neutrophils ≥ 1500/μL; platelets ≥ 100,000/μL, normal renal and liver function. Treatment consisted of six courses of weekly topotecan (2 mg/m2) and cisplatin (40 mg/m 2). All responsive and stable patients were submitted to radical surgery, while progressed cases underwent definitive radiotherapy ± chemotherapy. Primary end-point was evaluation of efficacy and toxicity. All patients are evaluable for toxicity and efficacy. Results: Ninety-six percent of patients completed the six planned courses of chemotherapy, and 95% of courses were administered at a full dose and without interruption or delay. Mean age was 49 years (35-64 years). FIGO Stage distribution was 30 IB2, 13 IIA and 49 IIB. Treatment was well tolerated and no death occurred. G3-G4 haematological toxicity was observed in 28% of patients (5% out of cycles). Support therapies (blood transfusions and/or erythropoietin and/or Granocyte-Colony Stimulating Factor) were given to 24% of patients. Clinical response rate was 77%. The nine progressed cases were irradiated, while the remaining 83 patients were submitted to radical surgery. An overall pathologic response was observed in 67% of patients, with an optimal response rate of 32% and a disease downstage in 57% of patients. Nodal metastases occurred in 36% of patients. Adjuvant therapy (radiotherapy and or chemotherapy) was prescribed in 55% of patients, because of lymph node metastases, parametrial or vaginal involvement or cut-through margins. Median follow-up was 18 months: 76% of patients are alive and free from recurrence, 24% of patients relapsed and 13% died. Conclusions: Weekly topotecan and cisplatin showed an acceptable toxicity profile; the promising response rate warrants further investigation.
AB - Objectives: The aim of this phase II multicentric study was to evaluate the efficacy and toxicity of neo-adjuvant chemotherapy with weekly topotecan and cisplatin in locally-advanced squamous cervical cancer. Patients and methods: From November 2008 to January 2011, 92 patients met the inclusion criteria and were enrolled. Eligibility criteria were: squamous or adenosquamous cervical cancer; clinical stages IB2, IIA, IIB; Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2; neutrophils ≥ 1500/μL; platelets ≥ 100,000/μL, normal renal and liver function. Treatment consisted of six courses of weekly topotecan (2 mg/m2) and cisplatin (40 mg/m 2). All responsive and stable patients were submitted to radical surgery, while progressed cases underwent definitive radiotherapy ± chemotherapy. Primary end-point was evaluation of efficacy and toxicity. All patients are evaluable for toxicity and efficacy. Results: Ninety-six percent of patients completed the six planned courses of chemotherapy, and 95% of courses were administered at a full dose and without interruption or delay. Mean age was 49 years (35-64 years). FIGO Stage distribution was 30 IB2, 13 IIA and 49 IIB. Treatment was well tolerated and no death occurred. G3-G4 haematological toxicity was observed in 28% of patients (5% out of cycles). Support therapies (blood transfusions and/or erythropoietin and/or Granocyte-Colony Stimulating Factor) were given to 24% of patients. Clinical response rate was 77%. The nine progressed cases were irradiated, while the remaining 83 patients were submitted to radical surgery. An overall pathologic response was observed in 67% of patients, with an optimal response rate of 32% and a disease downstage in 57% of patients. Nodal metastases occurred in 36% of patients. Adjuvant therapy (radiotherapy and or chemotherapy) was prescribed in 55% of patients, because of lymph node metastases, parametrial or vaginal involvement or cut-through margins. Median follow-up was 18 months: 76% of patients are alive and free from recurrence, 24% of patients relapsed and 13% died. Conclusions: Weekly topotecan and cisplatin showed an acceptable toxicity profile; the promising response rate warrants further investigation.
KW - Cervical cancer
KW - Cisplatin
KW - Neoadjuvant therapy
KW - Topotecan
KW - Treatment efficacy
KW - Treatment toxicity
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U2 - 10.1016/j.ejca.2012.10.008
DO - 10.1016/j.ejca.2012.10.008
M3 - Article
C2 - 23151423
AN - SCOPUS:84874932598
VL - 49
SP - 1065
EP - 1072
JO - European Journal of Cancer
JF - European Journal of Cancer
SN - 0959-8049
IS - 5
ER -