Phase II Trial of Paclitaxel and Cisplatin in Metastatic and Recurrent Carcinoma of the Uterine Cervix

Papadimitriou, Christos; Sarris, K.; Moulopoulos, Lia A.; Fountzilas, George; Anagnostopoulos, Athanasios K.; Voulgaris, Zannis; Gika, Dimitra; Giannakoulis, Nikolaos; Diakomanolis, Emmanuel; Dimopoulos, Meletios A.

doi:10.1200/jco.1999.17.3.761

Cited by 99 publications

(56 citation statements)

References 25 publications

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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%

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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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Section: Discussionmentioning

confidence: 99%

“…Many combination chemotherapy regimens have also been explored during the last two decades. High response rates have been obtained in some studies, but it is difficult to assess the relative merits of the various regimens because of differences in patient selection (Buxton et al, 1989;Papadimitriou et al, 1999).…”

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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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“…However, if CHFR is inactive, damaged DNA cannot be repaired and continuation of somatic cell division leads to apoptosis and increased sensitivity to paclitaxel. Cervical adenocarcinoma has lower sensitivity to anticancer agents compared with cervical SCC (9), and has higher sensitivity to these agents if CHFR is epigenetically suppressed (10). Thus, the aberrant hypermethy lation of CHFR in cervical adenocarcinoma is a candidate biomarker for sensitivity to paclitaxel.…”

Section: Biomarkers Associated With Sensitivity To Anticancer Agentsmentioning

confidence: 99%

Candidate biomarkers for cervical cancer treatment: Potential for clinical practice (Review)

Iida

Banno

Yanokura

et al. 2014

Molecular and Clinical Oncology

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Abstract. Cervical cancer ranks high among the causes of female cancer mortalities and is an important disease in developing and developed countries. Current diagnosis of cervical cancer depends on colposcopy, pathological diagnosis and preoperative diagnosis using methods, including magnetic resonance imaging and computed tomography. Advanced cervical cancer has a poor prognosis. The tumor marker squamous cell carcinoma is conventionally used for screening, but recent studies have revealed the mechanisms of carcinogenesis and the factors associated with a poor prognosis in cervical cancer. These include epigenetic biomarkers, with the methylation level of the checkpoint with forkhead and ring finger gene being potentially useful for predicting the malignancy of cervical cancer and sensitivity to treatment with paclitaxel.

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“…The rationales of using paclitaxel in combination with cisplatin in concurrent chemoradiation are that 1) paclitaxel acts as a radiosensitizer in vitro, 7,8 2) a phase I study with cisplatin plus paclitaxel has proved excellent overall response in patients with locally advanced cervical cancer, 9 and 3) cisplatin plus paclitaxel have activity against metastatic and recurrent cervical cancer. 10 Recently, several studies which used cisplatin plus paclitaxel with concurrent radiation have been reported. 9,[11][12][13] These were phase I and/or II studies which focused on evaluating toxicities and response rates in a limited number of enrolled patients.…”

Section: Introductionmentioning

confidence: 99%

Comparison of concurrent chemoradiotherapy with cisplatin plus 5-fluorouracil versus cisplatin plus paclitaxel in patients with locally advanced cervical carcinoma

et al. 2009

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Objective: The aim of this study was to compare survival outcomes and toxicities between concurrent radiotherapy with cisplatin plus 5-fluorouracil and that with cisplatin plus paclitaxel in patients with locally advanced cervical carcinoma. Methods:We retrospectively reviewed data from 93 locally advanced cervical carcinoma patients (stage IB to IVA) who had been treated by concurrent radiotherapy with cisplatin plus 5-fluorouracil (CF, n=45) vs. cisplatin plus paclitaxel (CP, n=48) as primary therapy. Toxicities and survival outcomes were compared. Results: In the CP group, there were higher frequencies of severe (grade 3 or 4) leukopenia (79.2%, as compared to 11.1% in the CF group), severe neutropenia (77.1%, as compared to 8.9% in the CF group) and severe peripheral neuropathy (12.5%, as compared to 2.2% in the CF group). In the CF group, there were higher frequencies of severe nausea (33.3%, as compared to 14.6% in the CP group) and severe hyponatremia (11.1%, as compared to 0% in the CP group). Five-year DFS of the CF and CP groups was 67.4% and 79.1%, respectively (p=NS). Five year OS of the CF and CP groups was 79.6% and 80.9%, respectively (p=NS). Conclusion: Concurrent radiotherapy with cisplatin plus paclitaxel showed increased leukopenia, neutropenia and peripheral neuropathy, but less gastrointestinal toxicity (nausea) than that with cisplatin plus 5-fluorouracil. Survival outcome between these two groups was not statistically different in this study. Large prospective randomized controlled studies will be needed to confirm this result.

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Phase II Trial of Paclitaxel and Cisplatin in Metastatic and Recurrent Carcinoma of the Uterine Cervix

Cited by 99 publications

References 25 publications

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

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

Candidate biomarkers for cervical cancer treatment: Potential for clinical practice (Review)

Comparison of concurrent chemoradiotherapy with cisplatin plus 5-fluorouracil versus cisplatin plus paclitaxel in patients with locally advanced cervical carcinoma

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