[Adjuvant chemotherapy of cervix carcinoma--results of a phase II study]

• Abstract: OBJECTIVE: Therapies involving a radical operation and radiation treatment for cervical carcinoma in stages I and II are not sufficiently effective in patient subgroups with high risk for recurrence. In recent publications, patients with high risk cervical cancer had with adjuvant simultaneous radio-chemotherapy a better disease free and overall survival but a higher toxicity compared with patients received an adjuvant radiotherapy alone. MATERIAL AND METHODS: 34 patients with at least 2 risk factors for recurrence of cervical cancer were treated with adjuvant chemotherapy after radical hysterectomy. The protocol consisted of 3 cycles of ifosfamide 1.6 g/m2 (d 1-3) and carboplatin (AUC 4, d1) every three weeks. For cell protection 21 patients received amifostine 740 mg/m2 d1-3; this was followed by standard radiation therapy (50.4 Gy percutaneous and high-dose-rate-after-loading for 21 patients, 2 x 5 Gy). The dose determination of the substances and their toxicity were investigated. RESULTS: Patient (p) data: Median age 43 years (range: 25-70); pT1b-2a: n = 22; pT2b: n = 12; pN1: n = 28; pN0: n = 6; G3: n = 10; adeno- and adenosquamous carcinoma: n = 9, G3: n = 10, R1-resection: n = 5. 70.6% of these high-risk patients were disease-free after a median observation time of 40 (18-62) months. Median number of cycles of chemotherapy: 2.8. There was no more dose escalation than carboplatin according to AUC 4 possible. Hematologic toxicity (CTC grading, % of 96 documented cycles): anemia-grade 3-4: 30; -grade 1-2: 10.4; leukopenia-grade 3-4: 13, -grade 1-2: 21.7; alopecia-grade 3: all p.; cerebral neurotoxicity-grade 3-4: 8.3, -grade 1-2; 17.7; diarrhea under radiotherapy-grade 3-4: 2 p., -grade 1-2: 6 p. CONCLUSION: This combined sequential adjuvant therapy was effective and had an acceptable level of toxicity. A phase III study comparing adjuvant sequential chemo-radiotherapy with and without Erythropoeitin to counteract the negative effects of anemia started in Germany in 1999 and had randomized now about 270 patients.
• Authors: J U Blohmer, S Paepke, D Böhmer, B Ernhardt, J Sehouli, D Elling, W Lichtenegger (Affiliation: Klinik für Geburtshilfe und Frauenheilkunde der Charité, Humboldt-Universität zu Berlin. jens-u.blohmer at charite.de)
• Journal: Zentralblatt für Gynäkologie (Zentralbl Gynakol) Vol. 123 Issue 5 Pg. 286-91 (May 2001) ISSN: 0044-4197 [Print] Germany
• Vernacular Title: Die adjuvante Chemotherapie des Zervixkarzinoms-Ergebnisse einer Phase II-Studie.
• PMID: 11449622 (Publication Type: Clinical Trial, Clinical Trial, Phase II, English Abstract, Journal Article, Randomized Controlled Trial)

Chemical References

• Amifostine
• Ifosfamide
• Carboplatin

Topics

• Adenocarcinoma (drug therapy, pathology, radiotherapy, surgery)
• Adult
• Aged
• Amifostine (administration & dosage, adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carboplatin (administration & dosage, adverse effects)
• Carcinoma, Adenosquamous (drug therapy, pathology, radiotherapy, surgery)
• Chemotherapy, Adjuvant
• Combined Modality Therapy
• Disease-Free Survival
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Hysterectomy
• Ifosfamide (administration & dosage, adverse effects)
• Middle Aged
• Neoplasm Staging
• Radiotherapy, Adjuvant
• Uterine Cervical Neoplasms (drug therapy, pathology, radiotherapy, surgery)