Chemotherapy for stage III-IV epithelial ovarian cancer with cis-dichlorodiammineplatinum(II), adriamycin, and cyclophosphamide: A preliminary report

C. E. Ehrlich, Lawrence Einhorn, S. D. Williams, MorganJ.

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Abstract

This study was designed to evaluate the effectiveness of cis-dichlorodiammineplatinum(II) (cis-platinum), adriamycin, and cyclophosphamide (PAC) as primary therapy for advanced ovarian cancer and to compare a 1-day versus a 5-day schedule for administering cis-platinum to determine the superior schedule for response and toxicity. Patients were randomized between two schemes: PAC-V - cis-platinum at a dose of 20 mg/m2iv daily for 5 days, adriamycin at a dose of 50 mg/m2 iv on Day 1, and cyclophosphamide at a dose of 750 mg/m2iv on Day 1; or PAC-I - cis-platinum at a dose of 50 mg/m2, adriamycin at a dose of 50 mg/m2, and cyclophosphamide at a dose of 750 mg/m2, all on Day 1. PAC-V was repeated every 4 weeks and PAC-I was repeated every 3 weeks. All treatment with cis-platinum was given to patients in the hospital with posttreatment iv hydration. cis-Platinum was discontinued at a total dose of 300 mg/m2 and adriamycin was discontinued at a total dose of 450 mg/m2; thereafter, cyclophosphamide was increased by 20% and was given orally every 4 weeks. Thirty-five of 39 patients who were entered in this study are evaluable. PAC is an active drug combination against advanced epithelial ovarian cancer with an overall response rate of 68.5%, a complete response rate of 37%, and a partial response rate of 31.5%. The interval to response was 4-12 weeks. Hematologic toxicity was severe, with all patients developing a leukopenia of <2000 cells/mm3 and 51% of the patients developing a leukopenia of <1000 cells/mm3. Thrombocytopenia was moderate in most patients with 28% of the patients developing a thrombocytopenia of <50,000 cells/mm3. Hemoglobin levels of <9.5 g/100 ml developed in 86% of the patients; 67% of PAC-I and 29% of PAC-V patients required transfusions for symptomatic anemia. Dose-limiting nephrotoxicity was seen in two patients early in the use of this combination. Posttreatment iv hydration of patients in the hospital has limited the nephrotoxicity; 46% of the patients had a BUN level of 21-40 mg/100 ml and/or a serum creatinine level of 1.3-2.0 mg/100 ml. No progressive nephrotoxicity was observed after discontinuing the cis-platinum, and cardiac toxicity was seen in only one patient. Nausea, vomiting, and alopecia were seen in all patients while no significant neurotoxicity or ototoxicity was observed.

Original languageEnglish
Pages (from-to)281-288
Number of pages8
JournalCancer Treatment Reports
Volume63
Issue number2
StatePublished - 1979

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Doxorubicin
Cyclophosphamide
Cisplatin
Drug Therapy
Leukopenia
Ovarian epithelial cancer
Thrombocytopenia
Appointments and Schedules
Blood Urea Nitrogen
Alopecia
Drug Combinations
Ovarian Neoplasms
Nausea
Vomiting
Anemia
Creatinine
Hemoglobins

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Chemotherapy for stage III-IV epithelial ovarian cancer with cis-dichlorodiammineplatinum(II), adriamycin, and cyclophosphamide : A preliminary report. / Ehrlich, C. E.; Einhorn, Lawrence; Williams, S. D.; MorganJ.

In: Cancer Treatment Reports, Vol. 63, No. 2, 1979, p. 281-288.

Research output: Contribution to journalArticle

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abstract = "This study was designed to evaluate the effectiveness of cis-dichlorodiammineplatinum(II) (cis-platinum), adriamycin, and cyclophosphamide (PAC) as primary therapy for advanced ovarian cancer and to compare a 1-day versus a 5-day schedule for administering cis-platinum to determine the superior schedule for response and toxicity. Patients were randomized between two schemes: PAC-V - cis-platinum at a dose of 20 mg/m2iv daily for 5 days, adriamycin at a dose of 50 mg/m2 iv on Day 1, and cyclophosphamide at a dose of 750 mg/m2iv on Day 1; or PAC-I - cis-platinum at a dose of 50 mg/m2, adriamycin at a dose of 50 mg/m2, and cyclophosphamide at a dose of 750 mg/m2, all on Day 1. PAC-V was repeated every 4 weeks and PAC-I was repeated every 3 weeks. All treatment with cis-platinum was given to patients in the hospital with posttreatment iv hydration. cis-Platinum was discontinued at a total dose of 300 mg/m2 and adriamycin was discontinued at a total dose of 450 mg/m2; thereafter, cyclophosphamide was increased by 20{\%} and was given orally every 4 weeks. Thirty-five of 39 patients who were entered in this study are evaluable. PAC is an active drug combination against advanced epithelial ovarian cancer with an overall response rate of 68.5{\%}, a complete response rate of 37{\%}, and a partial response rate of 31.5{\%}. The interval to response was 4-12 weeks. Hematologic toxicity was severe, with all patients developing a leukopenia of <2000 cells/mm3 and 51{\%} of the patients developing a leukopenia of <1000 cells/mm3. Thrombocytopenia was moderate in most patients with 28{\%} of the patients developing a thrombocytopenia of <50,000 cells/mm3. Hemoglobin levels of <9.5 g/100 ml developed in 86{\%} of the patients; 67{\%} of PAC-I and 29{\%} of PAC-V patients required transfusions for symptomatic anemia. Dose-limiting nephrotoxicity was seen in two patients early in the use of this combination. Posttreatment iv hydration of patients in the hospital has limited the nephrotoxicity; 46{\%} of the patients had a BUN level of 21-40 mg/100 ml and/or a serum creatinine level of 1.3-2.0 mg/100 ml. No progressive nephrotoxicity was observed after discontinuing the cis-platinum, and cardiac toxicity was seen in only one patient. Nausea, vomiting, and alopecia were seen in all patients while no significant neurotoxicity or ototoxicity was observed.",
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N2 - This study was designed to evaluate the effectiveness of cis-dichlorodiammineplatinum(II) (cis-platinum), adriamycin, and cyclophosphamide (PAC) as primary therapy for advanced ovarian cancer and to compare a 1-day versus a 5-day schedule for administering cis-platinum to determine the superior schedule for response and toxicity. Patients were randomized between two schemes: PAC-V - cis-platinum at a dose of 20 mg/m2iv daily for 5 days, adriamycin at a dose of 50 mg/m2 iv on Day 1, and cyclophosphamide at a dose of 750 mg/m2iv on Day 1; or PAC-I - cis-platinum at a dose of 50 mg/m2, adriamycin at a dose of 50 mg/m2, and cyclophosphamide at a dose of 750 mg/m2, all on Day 1. PAC-V was repeated every 4 weeks and PAC-I was repeated every 3 weeks. All treatment with cis-platinum was given to patients in the hospital with posttreatment iv hydration. cis-Platinum was discontinued at a total dose of 300 mg/m2 and adriamycin was discontinued at a total dose of 450 mg/m2; thereafter, cyclophosphamide was increased by 20% and was given orally every 4 weeks. Thirty-five of 39 patients who were entered in this study are evaluable. PAC is an active drug combination against advanced epithelial ovarian cancer with an overall response rate of 68.5%, a complete response rate of 37%, and a partial response rate of 31.5%. The interval to response was 4-12 weeks. Hematologic toxicity was severe, with all patients developing a leukopenia of <2000 cells/mm3 and 51% of the patients developing a leukopenia of <1000 cells/mm3. Thrombocytopenia was moderate in most patients with 28% of the patients developing a thrombocytopenia of <50,000 cells/mm3. Hemoglobin levels of <9.5 g/100 ml developed in 86% of the patients; 67% of PAC-I and 29% of PAC-V patients required transfusions for symptomatic anemia. Dose-limiting nephrotoxicity was seen in two patients early in the use of this combination. Posttreatment iv hydration of patients in the hospital has limited the nephrotoxicity; 46% of the patients had a BUN level of 21-40 mg/100 ml and/or a serum creatinine level of 1.3-2.0 mg/100 ml. No progressive nephrotoxicity was observed after discontinuing the cis-platinum, and cardiac toxicity was seen in only one patient. Nausea, vomiting, and alopecia were seen in all patients while no significant neurotoxicity or ototoxicity was observed.

AB - This study was designed to evaluate the effectiveness of cis-dichlorodiammineplatinum(II) (cis-platinum), adriamycin, and cyclophosphamide (PAC) as primary therapy for advanced ovarian cancer and to compare a 1-day versus a 5-day schedule for administering cis-platinum to determine the superior schedule for response and toxicity. Patients were randomized between two schemes: PAC-V - cis-platinum at a dose of 20 mg/m2iv daily for 5 days, adriamycin at a dose of 50 mg/m2 iv on Day 1, and cyclophosphamide at a dose of 750 mg/m2iv on Day 1; or PAC-I - cis-platinum at a dose of 50 mg/m2, adriamycin at a dose of 50 mg/m2, and cyclophosphamide at a dose of 750 mg/m2, all on Day 1. PAC-V was repeated every 4 weeks and PAC-I was repeated every 3 weeks. All treatment with cis-platinum was given to patients in the hospital with posttreatment iv hydration. cis-Platinum was discontinued at a total dose of 300 mg/m2 and adriamycin was discontinued at a total dose of 450 mg/m2; thereafter, cyclophosphamide was increased by 20% and was given orally every 4 weeks. Thirty-five of 39 patients who were entered in this study are evaluable. PAC is an active drug combination against advanced epithelial ovarian cancer with an overall response rate of 68.5%, a complete response rate of 37%, and a partial response rate of 31.5%. The interval to response was 4-12 weeks. Hematologic toxicity was severe, with all patients developing a leukopenia of <2000 cells/mm3 and 51% of the patients developing a leukopenia of <1000 cells/mm3. Thrombocytopenia was moderate in most patients with 28% of the patients developing a thrombocytopenia of <50,000 cells/mm3. Hemoglobin levels of <9.5 g/100 ml developed in 86% of the patients; 67% of PAC-I and 29% of PAC-V patients required transfusions for symptomatic anemia. Dose-limiting nephrotoxicity was seen in two patients early in the use of this combination. Posttreatment iv hydration of patients in the hospital has limited the nephrotoxicity; 46% of the patients had a BUN level of 21-40 mg/100 ml and/or a serum creatinine level of 1.3-2.0 mg/100 ml. No progressive nephrotoxicity was observed after discontinuing the cis-platinum, and cardiac toxicity was seen in only one patient. Nausea, vomiting, and alopecia were seen in all patients while no significant neurotoxicity or ototoxicity was observed.

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