Results of a European Organization for Research and Treatment of Cancer/Early Clinical Studies Group Phase II Trial of First-Line Irinotecan in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Cervix
To determine the efficacy and tolerability of irinotecan (CPT-11) in advanced or recurrent cervical carcinoma.
Eligible patients had histologically confirmed, inoperable, progressive, metastatic or recurrent squamous cell cervical carcinoma and had received no radiotherapy in the preceding 3 months and had never received chemotherapy. The initial irinotecan dosage of 350 mg/m(2) every 3 weeks was modifiable according to toxicity. Treatment continued for six cycles after complete response, or until disease progression or excessive toxicity after partial response, or for three additional cycles in the case of stable disease. Patients were stratified into group A (>/= one measurable lesion in a previously unirradiated area, with or without progressive disease in irradiated fields) or group B (measurable new lesion[s] in an irradiated field).
Fifty-one of 55 enrolled patients were eligible for inclusion (median age, 47 years; range, 30 to 71 years). The response rate was 15.7% (95% confidence interval [CI], 7.0% to 28.6%) overall, 23.5% (95% CI, 10.7% to 41.2%) for group A (complete response, 2.9%), and zero for group B. The median time to progression and median survival were 4.0 and 8.2 months for group A and 2.5 and 4.2 months for group B, respectively. The major grade 3/4 toxicities for groups A and B were diarrhea (24.3% and 55.5%, respectively) and neutropenia (24.3% and 33.3%, respectively). There were four toxicity-related deaths, three in group B. Patients with no prior external pelvic irradiation experienced fewer grade 3 and 4 adverse events.
Irinotecan is effective in treating cervical squamous cell carcinoma if disease is located in an unirradiated area. Because of toxicity, a reduced dose is advised for patients previously treated with external pelvic irradiation.
CME Journal of Gynecologic Oncology 01/2000; 5(3).
Available from: Jan B Vermorken
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ABSTRACT: 2 ABSTRACT A review is given of the standard approaches in the management of patients with newly diagnosed and recurrent cervical cancer. New directions in treatment are discussed. They focus on the following topics: the usefulness of short and dose intensive single-agent cisplatin regimens, the role of hyperthermia in combination with chemotherapy and/or radi- ation therapy, the availability of some interesting new cytoto- xic agents, recent outcomes of some combined modality stu- dies in high-risk patients, and the role of hemoglobin levels at the time of treatment. It is concluded that further improve- ment in radiotherapy techniques will be a major challenge. Chemoradiation is considered the new standard for high-risk patients, who in the past would have been treated with radia- tion therapy alone. The preferred chemotherapy regimen for that purpose is single-agent cisplatin given at a dose of 40 mg/m 2 /week. Attention should be given to the usefulness of hyperthermia in combination with radiation therapy, chemo- therapy or both. Moreover, further study is needed with agents with a stronger radio-enhancement potential, while maneuvers to maintein normal levels of tumor oxygenation should be an important component of therapy. Neoadjuvant chemotherapy followed by radiotherapy for the treatment of patients with locally advanced cervical cancer cannot be re- commended, but its use prior to surgery needs to be further explored. Uncertainty about the potential role of adjuvant chemotherapy remains. Quality of life issues should be high on the list of priorities when treating patients with recurrent disease.
CME Journal of Gynecologic Oncology 01/2001; 6(1).
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ABSTRACT: The activity and toxicity of topotecan in women with recurrent cervical cancer are described from a case series of women with recurrent cervical cancer who had measurable disease and were not amenable to cure by surgery or radiation. All patients had prior platinum-based chemotherapy and developed progressive disease. Topotecan was given as 1 mg/m2/day over 30 min for 5 days every 3 weeks until progression of disease or prohibitive toxicity. Between July 1998 and July 1999, 12 patients received a total of 20 cycles of topotecan. Median age was 41 years (range 21-62), and 11 (92%) patients had prior whole pelvic radiation. The mean number of topotecan cycles was 1.5 (median 1, range 1-3). There were two partial responses (16.7%; 95% CI, 2% to 48%), both in prior radiation fields. Five patients required red blood cell transfusions, four had grade II nausea and vomiting, two developed sepsis (one with neutropenia), one developed fever, and one reported hyperpigmentation. There were no treatment-related mortalities. Although topotecan appears to exhibit modest activity in recurrent cervical cancer after radiation and platinum-based therapy, bone marrow toxicity may limit the utility of this regimen without hematopoietic growth factor support.
International Journal of Gynecological Cancer 08/2000; 10(4):285-288. DOI:10.1046/j.1525-1438.2000.010004285.x · 1.95 Impact Factor
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