Phase II trial of bleomycin, ifosfamide, and carboplatin in metastatic cervical cancer.

Murad, André M.; Triginelli, Sérgio A.; Ribalta, Julisa Chamorro Lascasas

doi:10.1200/jco.1994.12.1.55

Cited by 42 publications

(29 citation statements)

References 10 publications

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“…Bolis et al [38]observed that the association cisplatin and ifosfamide in a neoadjuvant fashion achieved a pathological response rate of 69%, with 5% complete response in patients with cervical carcinoma stage IB–IIB, and these data were similar to those reported by other investigators [25, 39]. …”

Section: Neoadjuvant Treatmentsupporting

confidence: 81%

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Role of Ifosfamide in Cervical Cancer: An Overview

Buda¹,

Dell’Anna²,

Signorelli³

et al. 2003

Oncology

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Ifosfamide, a cyclophosphamide analogue, has demonstrated a wide spectrum of activity against numerous neoplasms in different oncologic areas, including paediatric, haematological, breast, lung and testicular cancers, soft tissue sarcomas and gynaecological cancer. In gynaecologic cancers in particular, evidence suggests activity in the treatment of epithelial ovarian cancer, cervical carcinoma, germ cell carcinoma of the ovary. Cervical cancer has long been considered a poorly chemosensitive tumour and for several years the role of chemotherapy in the treatment of this tumour was confined to persistent or recurrent disease after failure of surgery and/or radiotherapy. In the management of cervical cancer, chemotherapy has received increasing attention in the last two decades and is currently used in neoadjuvant regimens, as salvage treatment in patients with disseminated or recurrent disease, or as a radiosensitizer. Over the past 30 years, several agents have been tested but cisplatin and ifosfamide are the agents that have attracted the greater attention. Cisplatin represents the cornerstone of chemotherapy for cervical cancer. Ifosfamide has been studied as a single agent or in combination with other drugs in different studies. In this paper we reviewed the approach with systemic therapy and, in particular, the role of ifosfamide in advanced or recurrent, and less advanced cervical cancer.

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Section: Neoadjuvant Treatmentsupporting

confidence: 81%

“…Several phase II trails using this regimen have documented response rates ranging from a low of 13% to a high of 100% [22, 23, 24, 25, 26]. However, the majority of these trials, particularly those that included patients with no previous radiation therapy, documented response rates in the 65–100% range.…”

Section: Advanced or Recurrent Diseasementioning

confidence: 99%

Role of Ifosfamide in Cervical Cancer: An Overview

Buda¹,

Dell’Anna²,

Signorelli³

et al. 2003

Oncology

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“…Several combination chemotherapy regimens that contain cisplatin have been tested in phase II studies, and objective responses have been documented in 30 -70% of the patients, while the median overall survival time ranged between 7 and 12 months (Buxton et al, 1989;Murad et al, 1994;Long et al, 1995;Papadimitriou et al, 1997Papadimitriou et al, , 1999Rose et al, 1999). Although it is difficult to directly compare the relative merits of the combined regimens with the single agents, combination chemotherapy seems to be superior to single-agent therapy based on these phase II studies.…”

Section: Discussionmentioning

confidence: 99%

Phase I–II study of irinotecan (CPT-11) plus nedaplatin (254-S) with recombinant human granulocyte colony-stimulating factor support in patients with advanced or recurrent cervical cancer

Tsuda

Hashiguchi

Nishimura³

et al. 2004

Br J Cancer

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Combination chemotherapy with irinotecan (CPT-11) and platinum compounds is effective for treating cervical cancer. Nedaplatin (254-S) is a new cisplatin analogue that achieves a high response rate (53%) in patients with primary cervical cancer. We performed a phase I -II study of combination chemotherapy with CPT-11 plus 254-S for advanced or recurrent cervical cancer. The inclusion criteria were stage IV disease or recurrence. CPT-11 and 254-S were administered intravenously on day 1, while rhG-CSF (50 mg) was given on days 3 -12. This regimen was repeated after 4 weeks. Dose escalation was carried out in tandem (CPT-11/254-S: 50/70, 50/80, and 60/80 mg m À2 ). A total of 27 patients (stage IV ¼ seven, recurrence ¼ 20) were enrolled. The phase I study enrolled eight patients. At dose levels 1 and 2, no dose-limiting toxicities were observed. At dose level 3, the first two patients developed DLTs. The maximum tolerated dose of CPT-11 and 254-S was 60 and 80 mg m À2 , respectively, and the recommended doses were 50 and 80 mg m À2 . Grade 3/4 haematologic toxicity occurred in 67% in phase II study, but there were no grade 3 nonhaematologic toxicities except fot nausea or lethargy. In all 27 patients, there were two complete responses (7%) and 14 Partial responses (52%), for an overall response rate of 59% (95% confidence interval: 39 -78%). Among the 12 responders with recurrent disease, the median time to progression and median survival were 161 days (range: 61 -711 days) and 415 days (range: 74 -801 days). This new regimen is promising for cervical cancer.

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“…Subsequent therapy and prognosis was not discussed in this trial. Murad et al 2 treated stage IV or recurrent squamous cell cancer of the cervix with carboplatin, 200 mg/m 2 IV on day 1; ifosfamide, 2 g/m 2 IV on days 1, 2 and 3; and bleomycin, 30 mg/m 2 IV on day 1 (BIC regimen). A response rate of 60% (21/35) was observed.…”

Section: Discussionmentioning

confidence: 99%

Neoadjuvant chemotherapy with carboplatin, ifosfamide, and peplomycin in advanced cervical squamous cell carcinoma

Nagano

Ozawa

Suzuki

et al. 1999

International Journal of Clinical Oncology

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Background. To control advanced cervical squamous cell carcinoma more effectively and more easily, we used neoadjuvant chemotherapy, with three drugs carboplatin, ifosfamide, and peplomycin (PIP), in a study performed from July 1990 to October 1994 in nine Institutions. Methods. Sixty-five patients with untreated, inoperable squamous cell carcinoma of the cervix were treated with carboplatin (300 mg/m 2 IV; low-dose PIP regimen, or T. Nagano ( ) · 400 mg/m 2 IV; high-dose PIP regimen) on day 1, ifosfamide (1000 mg/m 2 , IV) on days 1-3, and peplomycin (5 mg/body, IM) on days 1-6. The low-dose PIP was given between July 1990 and April 1992, and the high-dose PIP from May 1992 to October 1994. Results. Response rates for the low-and high-dose PIP regimens were 42.9% (12/28) and 59.5% (22/37), respectively. Measurable lesions were recognized in the cervix, pelvic lymph node (PeN), paraaortic lymph node (PAN), lung, and supraclavicular lymph node. Response rates in these individual lesions to our low-and high-dose PIP regimens were 35.7% (10/28) and 55.6% (20/36), respectively in the cervical lesion and more than 50% for both regimens in the PeN and PAN metastatic lesions, while the supraclavicular lymph node metastatic lesions responded poorly to both regimens. After low-dose PIP, surgery was performed in 2 patients (2/28; 7.1%), while after high-dose PIP, 12 patients (12/37; 32.4%) underwent surgery. The 3-year survival rate of patients with high-dose PIP was significantly higher than that of those with low-dose PIP (P Ͻ 0.01). Conclusions. Neoadjuvant chemotherapy with PIP appears feasible and effective. The link between dosage and treatment response and achievable surgery rate and survival rates suggests that results might be further optimized by considering patients' renal function, and utilizing the Calvert formula for dosing analysis.

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Phase II trial of bleomycin, ifosfamide, and carboplatin in metastatic cervical cancer.

Abstract: BIC can be administered on an outpatient basis and seems to be effective in inducing tumor response and palliation in patients with disseminated squamous cell carcinoma of cervix, with a possible survival benefit for previously nonirradiated patients, with an acceptable toxicity profile.

Cited by 42 publications

References 10 publications

Role of Ifosfamide in Cervical Cancer: An Overview

Role of Ifosfamide in Cervical Cancer: An Overview

Phase I–II study of irinotecan (CPT-11) plus nedaplatin (254-S) with recombinant human granulocyte colony-stimulating factor support in patients with advanced or recurrent cervical cancer

Neoadjuvant chemotherapy with carboplatin, ifosfamide, and peplomycin in advanced cervical squamous cell carcinoma

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