Cyclophosphamide or ifosfamide in patients with advanced and/or recurrent endometrial carcinoma : a randomized phase II study of the EORTC Gynecological Cancer Cooperative Group
UNLABELLED: Currently, available chemotherapy regimens for patients with advanced or recurrent endometrial cancer are generally not curative. Thus, there is a need to identify more active single agents in this disease. In this study patients pre-treated and not pre-treated with first line combination chemotherapy were entered into a randomized phase II study of either cyclophosphamide (CYCLO) or Ifosfamide (IFOS).
PATIENTS AND METHOD: Sixty one eligible patients with recurrent or metastatic histologically proven, adenocarcinoma of the uterine corpus entered the study. The median age at entry was 62 (range 40-74) years. Twenty patients (33%) had prior hormonal treatment and 31 (51%) prior chemotherapy. CYCLO was given at a dose of 1200 mg/m2 and IFOS at a dose of 5 g/m2. Both drugs were administered i.v. over 24 hours on day one every three weeks. Adequate pre- and post hydration as well as use of Mesna in the Ifosfamide arm were mandatory.
RESULTS: A median of two treatment cycles (range 1-12) per patient were given. In the chemotherapy-naive patients, in the CYCLO arm two PRs (RR 14%, C.I. 2-43%) were seen and in the IFOS arm two CRs, two PRs, (RR 25%, C.I. 7-52%) were observed. No responses were seen in pre-treated patients. The duration of responses were: 15+, 7+ months for the CRs, 15+ and 5 months for PRs in IFOS arm and 67+, 4 months in CYCLO arm. The hematological toxicity was dose-limiting and similar in both treatment arms. No serious non hematological toxicities were reported, but a transient increase of the creatinine blood level was seen in two IFOS patients (6%).
CONCLUSION: Ifosfamide is an active drug in the treatment of chemotherapy-naive patients with advanced endometrial cancer and its application in currently used (combination) regimens should be considered.
| Medienart: |
Artikel |
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| Erscheinungsjahr: |
1999 |
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| Erschienen: |
1999 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:86 |
|---|---|
| Enthalten in: |
European journal of obstetrics, gynecology, and reproductive biology - 86(1999), 2 vom: 15. Okt., Seite 179-83 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Pawinski, A [VerfasserIn] |
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| Anmerkungen: |
Date Completed 23.11.1999 Date Revised 16.08.2019 published: Print Citation Status MEDLINE |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM104405546 |
|---|
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| 041 | |a eng | ||
| 100 | 1 | |a Pawinski, A |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Cyclophosphamide or ifosfamide in patients with advanced and/or recurrent endometrial carcinoma |b a randomized phase II study of the EORTC Gynecological Cancer Cooperative Group |
| 264 | 1 | |c 1999 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ohne Hilfsmittel zu benutzen |b n |2 rdamedia | ||
| 338 | |a Band |b nc |2 rdacarrier | ||
| 500 | |a Date Completed 23.11.1999 | ||
| 500 | |a Date Revised 16.08.2019 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a UNLABELLED: Currently, available chemotherapy regimens for patients with advanced or recurrent endometrial cancer are generally not curative. Thus, there is a need to identify more active single agents in this disease. In this study patients pre-treated and not pre-treated with first line combination chemotherapy were entered into a randomized phase II study of either cyclophosphamide (CYCLO) or Ifosfamide (IFOS) | ||
| 520 | |a PATIENTS AND METHOD: Sixty one eligible patients with recurrent or metastatic histologically proven, adenocarcinoma of the uterine corpus entered the study. The median age at entry was 62 (range 40-74) years. Twenty patients (33%) had prior hormonal treatment and 31 (51%) prior chemotherapy. CYCLO was given at a dose of 1200 mg/m2 and IFOS at a dose of 5 g/m2. Both drugs were administered i.v. over 24 hours on day one every three weeks. Adequate pre- and post hydration as well as use of Mesna in the Ifosfamide arm were mandatory | ||
| 520 | |a RESULTS: A median of two treatment cycles (range 1-12) per patient were given. In the chemotherapy-naive patients, in the CYCLO arm two PRs (RR 14%, C.I. 2-43%) were seen and in the IFOS arm two CRs, two PRs, (RR 25%, C.I. 7-52%) were observed. No responses were seen in pre-treated patients. The duration of responses were: 15+, 7+ months for the CRs, 15+ and 5 months for PRs in IFOS arm and 67+, 4 months in CYCLO arm. The hematological toxicity was dose-limiting and similar in both treatment arms. No serious non hematological toxicities were reported, but a transient increase of the creatinine blood level was seen in two IFOS patients (6%) | ||
| 520 | |a CONCLUSION: Ifosfamide is an active drug in the treatment of chemotherapy-naive patients with advanced endometrial cancer and its application in currently used (combination) regimens should be considered | ||
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 7 | |a Antineoplastic Agents, Alkylating |2 NLM | |
| 650 | 7 | |a Cyclophosphamide |2 NLM | |
| 650 | 7 | |a 8N3DW7272P |2 NLM | |
| 650 | 7 | |a Ifosfamide |2 NLM | |
| 650 | 7 | |a UM20QQM95Y |2 NLM | |
| 700 | 1 | |a Tumolo, S |e verfasserin |4 aut | |
| 700 | 1 | |a Hoesel, G |e verfasserin |4 aut | |
| 700 | 1 | |a Cervantes, A |e verfasserin |4 aut | |
| 700 | 1 | |a van Oosterom, A T |e verfasserin |4 aut | |
| 700 | 1 | |a Boes, G H |e verfasserin |4 aut | |
| 700 | 1 | |a Pecorelli, S |e verfasserin |4 aut | |
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