Cycles Q3w Research Articles

Docetaxel-cisplatin-5FU (TCF) versus docetaxel-cisplatin (TC) versus epirubicin-cisplatin-5FU (ECF) as systemic treatment for advanced gastric carcinoma (AGC): A randomized phase II trial of the Swiss Group for Clinical Cancer Research (SAKK)

4020 Background: ECF is currently considered by many as a standard regimen in AGC in Europe. Based on the high efficacy reported with TC and TCF in AGC (Ann. Oncol 11; 301, 2000, ASCO Proc. 18, 245a, 1999), we launched a randomized 3-arm phase II trial to assess which of TC or TCF would be the more promising regimen to compare to ECF in a future phase III trial. Methods: Patients (pts) with AGC, without prior palliative chemotherapy, with bidimentionally measurable disease, PS≤1, normal blood counts, hepatic and renal functions, were randomized to receive up to 8 cycles q3w of TC (docetaxel 85mg/m2, ciplatine 75mg/m2), TCF (like TC + 5-FU continuous infusion (CI) 300mg/m2/d for 2w) or ECF (epirubicin 50mg/m2, cisplatin 60mg/m2, 5-FU CI 200mg/m2/d for 3w). Results: Among 121pts enrolled, 119 were treated and included in the analysis. 5 pts are still on treatment (3 ECF and 2 TCF). Preliminary results are summarized below. A total of 554 treatment cycles are documented up to now. A median of 5, 4.5 and 4 cycles of ECF, TC and TCF were given, respectively. Hematotoxicity was the main toxicity in all 3 arms with grade ≥3 granulopenia in 73%, 76% and 58% of the pts for TC, TCF and ECF, respectively. Febrile neutropenia (FN) occurence in 10 of the first 21 pts enrolled in docetaxel based regimens led to decrease docetaxel from 85 to 75mg/m2 in TC and TCF, resulting in lesser FN occurence. Grade ≥3 non-hematologic toxicity was infrequent (<10% of pts) apart from alopecia (3 arms), nausea (18% in TC and TCF pts) and diarrhea (15% in TCF pts). Conclusions: Despite an increased toxicity, docetaxel based regimens seem to be more efficacious than ECF. In terms of RR and TTP, TCF is the more promising regimen and should be chosen for formal comparison with ECF. This trial is supported in part by Aventis. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis

Induction chemotherapy and following simultaneous radiochemotherapy versus induction chemotherapy and radiotherapy alone in inoperable NSCLC (Stage IIIA/IIIB): Update of CT/RT 99/97

7075 Background: In NSCLC simultaneous or induction radiochemotherapy is superior to chemo- or radiotherapy alone. Our study proves, weather after induction chemotherapy simultaneous radiochemotherapy is superior to radiotherapy alone. Methods: Patients (pts) with inoperable NSCLC IIIA/B are included. They get 2 cycles q3w of Paclitaxel 200mg/m2 and Carboplatinum AUC 6. If the tumor is not progressive the pts are randomized to radiotherapy alone (total dose at least 60 Gy per fraction) or simultaneous chemotherapy with weekly Paclitaxel 60mg/m2 and the same radiotherapy. Primary objective is survival; secondary endpoints are time to progression, response and toxicity. Results: Inclusion ended 05/02. The last follow-up was 11/03. As planned, 303 pts are included in the trial. 275 pts finished induction-therapy. 219 pts could be randomized: radiotherapy 115 pts, simultaneous radiochemotherapy 104 pts. Median survival is higher in the simultaneous arm: 18.67 months (95%CI 14.05–23.29) versus 14.1 months (95%...

Docetaxel-cisplatin-5FU (TCF) versus docetaxel-cisplatin (TC) versus epirubicin-cisplatin-5FU (ECF) as systemic treatment for advanced gastric carcinoma (AGC): A randomized phase II trial of the Swiss Group for Clinical Cancer Research (SAKK)

4020 Background: ECF is currently considered by many as a standard regimen in AGC in Europe. Based on the high efficacy reported with TC and TCF in AGC (Ann. Oncol 11; 301, 2000, ASCO Proc. 18, 245a, 1999), we launched a randomized 3-arm phase II trial to assess which of TC or TCF would be the more promising regimen to compare to ECF in a future phase III trial. Methods: Patients (pts) with AGC, without prior palliative chemotherapy, with bidimentionally measurable disease, PS≤1, normal blood counts, hepatic and renal functions, were randomized to receive up to 8 cycles q3w of TC (docetaxel 85mg/m2, ciplatine 75mg/m2), TCF (like TC + 5-FU continuous infusion (CI) 300mg/m2/d for 2w) or ECF (epirubicin 50mg/m2, cisplatin 60mg/m2, 5-FU CI 200mg/m2/d for 3w). Results: Among 121pts enrolled, 119 were treated and included in the analysis. 5 pts are still on treatment (3 ECF and 2 TCF). Preliminary results are summarized below. A total of 554 treatment cycles are documented up to now. A median of 5, 4.5 and 4 cycles of ECF, TC and TCF were given, respectively. Hematotoxicity was the main toxicity in all 3 arms with grade ≥3 granulopenia in 73%, 76% and 58% of the pts for TC, TCF and ECF, respectively. Febrile neutropenia (FN) occurence in 10 of the first 21 pts enrolled in docetaxel based regimens led to decrease docetaxel from 85 to 75mg/m2 in TC and TCF, resulting in lesser FN occurence. Grade ≥3 non-hematologic toxicity was infrequent (<10% of pts) apart from alopecia (3 arms), nausea (18% in TC and TCF pts) and diarrhea (15% in TCF pts). Conclusions: Despite an increased toxicity, docetaxel based regimens seem to be more efficacious than ECF. In terms of RR and TTP, TCF is the more promising regimen and should be chosen for formal comparison with ECF. This trial is supported in part by Aventis. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis

Induction chemotherapy and following simultaneous radiochemotherapy versus induction chemotherapy and radiotherapy alone in inoperable NSCLC (Stage IIIA/IIIB): Update of CT/RT 99/97

7075 Background: In NSCLC simultaneous or induction radiochemotherapy is superior to chemo- or radiotherapy alone. Our study proves, weather after induction chemotherapy simultaneous radiochemotherapy is superior to radiotherapy alone. Methods: Patients (pts) with inoperable NSCLC IIIA/B are included. They get 2 cycles q3w of Paclitaxel 200mg/m2 and Carboplatinum AUC 6. If the tumor is not progressive the pts are randomized to radiotherapy alone (total dose at least 60 Gy per fraction) or simultaneous chemotherapy with weekly Paclitaxel 60mg/m2 and the same radiotherapy. Primary objective is survival; secondary endpoints are time to progression, response and toxicity. Results: Inclusion ended 05/02. The last follow-up was 11/03. As planned, 303 pts are included in the trial. 275 pts finished induction-therapy. 219 pts could be randomized: radiotherapy 115 pts, simultaneous radiochemotherapy 104 pts. Median survival is higher in the simultaneous arm: 18.67 months (95%CI 14.05–23.29) versus 14.1 months (95%CI 11.64–16.56). Progression free survival is statistically superior (log rank: p=0.0003) in the simultaneous arm: median 11.43 months (95%CI 7.88–14.98) versus 5.57 months (95%CI 3.88–7.25). In the simultaneous arm there are also statistically less recurrences (Pearson Chi-Square: p<0.001): 62.1% vs. 83.8%. The reduction on recurrences can be seen in local as in distant relapses. Toxicities are not statistically different. Conclusions: The combination of induction chemotherapy and then simultaneous radiochemotherapy with weekly Paclitaxel is superior to induction alone regarding progression-free survival, without increased toxicities. Also the survival seems to be better (not yet statistically significant). Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb Germany Bristol-Myers Squibb

Early Intensified Chemotherapy with Autologous Bone Marrow Transplantation in First Line Treatment of Poor Risk Non-Seminomatous Germ Cell Tumours

For 30 months we have treated 115 non-pretreated non-seminomatous germ cell tumour (NSGCT) patients with poor risk characteristics. Patients were allocated randomly to either arm A: NCI regimen with vinblastine, etoposide (E), bleomycin and double dose cisplatin (P2) (PVeBV) 3 or 4 cycles Q3W, or arm B: modified PVeBV protocol (bleomycin in continuous infusion) Q4W than a cycle of high-dose E + cyclophosphamide + P2 (PEC) and autologous bone marrow transplantation (ABMT). 114 patients are evaluable: 81 testicular, 18 mediastinal and 15 retroperitoneal primaries. Arm A 57 patients: 7 patients did not complete the treatment. There were 15 failures, 9 PR, 33 CR. Seven patients relapsed. The 2-year survival is 82%. Arm B 57 patients: 16 patients did not complete the treatment. There were 26 failures, 7 PR and 24 CR. Nine patients relapsed. The 2-year survival is 60%. Both CR rates and survival are not statistically different. This trial fails to show any benefit of early intensified chemotherapy + ABMT to increase the CR and survival rates in poor risk NSGCT.