دورية أكاديمية
A randomised, prospective, phase III clinical trial of primary bleomycin, ifosfamide and cisplatin (BIP) chemotherapy followed by radiotherapy versus radiotherapy alone in inoperable cancer of the cervix.
| العنوان: | A randomised, prospective, phase III clinical trial of primary bleomycin, ifosfamide and cisplatin (BIP) chemotherapy followed by radiotherapy versus radiotherapy alone in inoperable cancer of the cervix. |
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| المؤلفون: | Herod J; CRC Trials Unit, Institute for Cancer Studies, University of Birmingham, Edgbaston, UK., Burton A, Buxton J, Tobias J, Luesley D, Jordan S, Dunn J, Poole CJ |
| المصدر: | Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2000 Sep; Vol. 11 (9), pp. 1175-81. |
| نوع المنشور: | Clinical Trial; Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: England NLM ID: 9007735 Publication Model: Print Cited Medium: Print ISSN: 0923-7534 (Print) Linking ISSN: 09237534 NLM ISO Abbreviation: Ann Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2020- : London : Elsevier Original Publication: Dordrecht ; Boston : Kluwer Academic Publishers, c1990- |
| مواضيع طبية MeSH: | Antineoplastic Combined Chemotherapy Protocols/*therapeutic use , Bleomycin/*therapeutic use , Cisplatin/*therapeutic use , Ifosfamide/*therapeutic use , Uterine Cervical Neoplasms/*drug therapy , Uterine Cervical Neoplasms/*radiotherapy, Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Bleomycin/adverse effects ; Cisplatin/adverse effects ; Female ; Humans ; Ifosfamide/adverse effects ; Middle Aged ; Neoplasm Staging ; Pelvis/radiation effects ; Prospective Studies ; Radiotherapy, Adjuvant ; Survival Rate ; Treatment Outcome ; Uterine Cervical Neoplasms/mortality |
| مستخلص: | Background: Phase II studies have shown primary (neo-adjuvant) chemotherapy with bleomycin, ifosfamide and cisplatin (BIP) is active against inoperable cervical cancer. We present here results of a randomised phase III multicentre trial comparing radical radiotherapy with neo-adjuvant BIP chemotherapy followed by radical radiotherapy in patients with inoperable cervical cancer, designed to discover whether this combination might improve survival. Patients and Methods: Patients with inoperable cervical carcinoma were randomised to pelvic radiotherapy alone [RT] or two to three cycles of bleomycin 30 units/24-hour infusion, ifosfamide 5 g/m2/24 hours, and cisplatin 50 mg/m2) chemotherapy followed by pelvic radiotherapy (BIP + RT). Randomisation was stratified by stage and radiotherapy centre. Results: One hundred seventy-two eligible women were randomised into this trial; eighty-six to RT and eighty-six to BIP + RT. A total of 190 cycles of chemotherapy were given. Median follow-up for the 47 patients still alive is 9 years with a minimum follow-up of 3 years. Complete or partial response occurred in 51 of 86 (59%) of those randomised to RT and 60 of 86 (69%) of those randomised to BIP + RT. The difference between response rates does not reach statistical significance (chi2 = 2.06, P = 0.15). Median survival is two years with an actuarial survival at five years of 32% (95% confidence interval (95% CI): 25%-39%). There is no significant difference between the treatment groups (chi2log-rank = 0.11, P = 0.74). Conclusions: This study does not show any survival benefit from the use of neo-adjuvant BIP chemotherapy in advanced cervical cancer. |
| المشرفين على المادة: | 11056-06-7 (Bleomycin) Q20Q21Q62J (Cisplatin) UM20QQM95Y (Ifosfamide) |
| SCR Protocol: | BIP protocol |
| تواريخ الأحداث: | Date Created: 20001104 Date Completed: 20010215 Latest Revision: 20200203 |
| رمز التحديث: | 20240627 |
| DOI: | 10.1023/a:1008346901733 |
| PMID: | 11061615 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 0923-7534 |
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| DOI: | 10.1023/a:1008346901733 |