First-line chemotherapy with paclitaxel by three-hour infusion and carboplatin in advanced breast cancer (final report): A phase II study conducted by the Hellenic Cooperative Oncology Group

Fountzilas, George; Dimopoulos, Meletios Α.; Papadimitriou, C.; Kalogera‐Fountzila, Anna; Aravantinos, G.; Bafaloukos, Dimitrios; Athanassiades, A.; Nicolaides, C.; Keramopoulos, Antonios; Pavlidis, Nicholas; Kosmidis, P.; Skarlos, Dimosthenis

doi:10.1023/a:1008466928323

Cited by 34 publications

(28 citation statements)

References 9 publications

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“…Severe side effects were infrequent. In general, the toxicity profile of the three regimens was similar to that shown in previously reported phase II studies with these regimens in patients with MBC [3][4][5][6][7][8][9]. The combination of gemcitabine and docetaxel was more myelotoxic than the other two regimens, while paclitaxel containing combinations were more neurotoxic.…”

Section: Discussionsupporting

confidence: 80%

“…In case of granulocytopenia or thrombocytopenia on the first day of the cycle, treatment was delayed until absolute neutrophil count (ANC) was C1,500/ll and platelets C100,000/ll, respectively. In case of severe toxicity the drug dosages of the three regimens were modified, as previously described [3,5,8]. Erythropoietin was recommended to all patients with a hemoglobin level of B11 g/dl.…”

Section: Dose Modificationmentioning

confidence: 99%

“…Three of them, paclitaxel and carboplatin [3,4], docetaxel and gemcitabine [5,6] and weekly paclitaxel [7][8][9] have demonstrated significant activity and manageable toxicity. Furthermore, the first of these combinations was found to be effective in a phase III trial [10], when compared to the combination of paclitaxel and epirubicin, in terms of overall response rate (ORR), survival and quality of life (QoL).…”

Section: Introductionmentioning

confidence: 99%

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A randomized phase III study comparing three anthracycline-free taxane-based regimens, as first line chemotherapy, in metastatic breast cancer

Fountzilas

Dafni

Dimopoulos

et al. 2008

Breast Cancer Res Treat

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Section: Discussionsupporting

confidence: 80%

Section: Dose Modificationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A randomized phase III study comparing three anthracycline-free taxane-based regimens, as first line chemotherapy, in metastatic breast cancer

Fountzilas

Dafni

Dimopoulos

et al. 2008

Breast Cancer Res Treat

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“…The averaged response rate was 59.6% (95% CI 54-65%) and the CR rate was 17.6% (95% CI 13.3-21.9%) (Table 5) (Decker et al, 1983;Boussen et al, 1991;Choo et al, 1991;Cvitkovic et al, 1991;Mahjoubi et al, 1992;Gebbia et al, 1993;Su et al, 1993;Chi et al, 1994Chi et al, , 1995Yeo et al, 1996;Fountzilas et al, 1997). Cases with complete remission had relatively long survival, especially cases with bone metastasis Su et al, 1993), but the prognosis of non-responders were grave (Hsu et al, 1983).…”

Section: Discussionmentioning

confidence: 99%

Induction with mitomycin C, doxorubicin, cisplatin and maintenance with weekly 5-fluorouracil, leucovorin for treatment of metastatic nasopharyngeal carcinoma: a phase II study

Hong

Sheen

et al. 1999

Br J Cancer

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The combination of cisplatin and 5-fluorouracil (5-FU) (PF) is the most popular regimen for treating metastatic nasopharyngeal carcinoma (NPC) but it is limited by severe stomatitis and chronic cisplatin-related toxicity. A novel approach including induction with mitomycin C, doxorubicin and cisplatin (MAP) and subsequent maintenance with weekly 5-FU and leucovorin (FL) were designed with an aim to reduce acute and chronic toxicity of PF. Thirty-two patients of NPC with measurable metastatic lesions in the liver or lung were entered into this phase II trial. Mitomycin C 8 mg m −2 , doxorubicin 40 mg m −2 and cisplatin 60 mg m −2 were given on day 1 every 3 weeks as initial induction. After either four courses or remission was achieved, patients received weekly dose of 5-FU 450 mg m −2 and leucovorin 30 mg m −2 for maintenance until disease progression. With 105 courses of MAP given, 5% were accompanied by grade 3 and 0% were accompanied by grade 4 stomatitis. The dose-limiting toxicity of MAP was myelosuppression. Forty per cent of courses had grade 3 and 13% of courses had grade 4 leukopenia. No grade 3 or 4 cisplatin-related toxicity was observed. The overall response rate was 94% (95% confidence interval (CI) 84.9–100%) with a complete response rate (CR) of 6% (95% CI: 0–15.2%) and a good partial response (PR) rate of 28% (95% CI 11.7–44.6%), which was optionally defined as observance of only equivocal lesion identifiable under imaging study. Twenty-seven cases entered weekly FL maintenance phase. The median duration of maintenance with weekly FL was 38 weeks (8–91 weeks). There was no grade 3 or 4 toxicity noted during weekly FL. The median progression-free survival and overall survival were 11.6 ± 0.4 and 18.1 ± 3.6 months respectively. Six patients with a median follow-up of 19.8 months (9.6–41.0 months) were still alive and five of them had disease under control with FL. Good responders (CR and good PR) had better survival than less satisfactory responders (PR and stable disease) ( P = 0.05). From Cox’s multivariate regression analysis, the only significant prognostic factor for survival was good response to MAP ( P = 0.042). Liver metastasis was the only significant variable in the best subset regression model that predicted good response to MAP (CR and good PR) ( P = 0.027). MAP was an effective combination for metastatic NPC with minimal stomatitis and cisplatin-related toxicity but had significant myelosuppression. Weekly FL was a maintenance therapy with minimal side-effects. The response rate and overall survival of MAP-FL were better than series previously reported even when a subset of patients with poor prognosis was selected. MAP-FL's role as neoadjuvant or adjuvant therapy is worthy of further study. © 1999 Cancer Research Campaign

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“…These patients participated in ten trials designed and run consecutively by HeCOG, exploring different first-line treatment options for patients with MBC [8][9][10][11][12][13][14][15][16][17]. Information was collected prospectively according to the corresponding trial protocol and deposited in the central HeCOG office database.…”

Section: Methodsmentioning

confidence: 99%

Fifteen-year trends in metastatic breast cancer survival in Greece

Dafni

Grimani

Xyrafas

et al. 2009

Breast Cancer Res Treat

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In the metastatic setting, a detected time trend to improved prognosis could be attributed to the corresponding recent advances in the therapeutic approaches. The aim of the current study was to first assess, in a large cohort of well over a thousand patients, the time trends in survival in MBC for the last 15 years and second to explore its association to prognostic factors affecting outcome including therapeutic regimen. This meta-analysis uses individual patient data collected from all the trials on MBC (6 nonrandomized, 4 randomized) conducted by HeCOG from 1991 through 2006. Four 4-year time periods (1991-1994, 1995-1998, 1999-2002, and 2003-2006) were constructed for exploration of time trends in survival according to the patient's date of metastatic diagnosis. Different first line regimens in the 10 trials include anthracycline monotherapy (epirubicin, in the early 1990s) and taxanecontaining regimens either as monotherapy or in different combinations with anthracyclines or other drugs. In two phase II studies and in the last randomized study, trastuzumab was administered in all the patients with HER2 overexpressing tumors. In this study, information is based on a total of 1361 patients with a median follow up of 3.7 years and median survival of 1.9 years (median survival 1.28, 1.68, 2.20, and 2.57 years for 1991-1994, 1995-1998, 1999-2002, and 2003-2006, respectively). Survival improved significantly across diagnosis time periods, by 25, 44, and 51%, respectively, in each time period (1995)(1996)(1997)(1998) (1991)(1992)(1993)(1994). The effect of metastatic diagnosis time period remains almost unchanged in the presence of the following significant prognostic factors: performance status, hormonal receptor status, previous adjuvant chemotherapy, previous adjuvant hormonal treatment, visceral metastasis at entry, and number of metastatic sites. When exploring the effect of new systemic treatment introduction, taking into account the same significant prognostic factors, the effect of diagnosis time period disappears, and the survival improvement is explained directly by the introduction of new agents (hormonal treatment for metastatic disease: yes vs. no: HR = 0.72, P \ 0.001; taxanes at first line: yes vs. no: HR = 0.69, P = 0.002; trastuzumab at first line: yes vs. no: HR = 0.63, P \ 0.001). The results of this study provide significant evidence of improvement in prognosis of MBC patients within the last 15 years, taking into account all the important significant prognostic factors, and this improvement can be attributed to the use of new systemic treatment agents in the management of the disease.

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First-line chemotherapy with paclitaxel by three-hour infusion and carboplatin in advanced breast cancer (final report): A phase II study conducted by the Hellenic Cooperative Oncology Group

Cited by 34 publications

References 9 publications

A randomized phase III study comparing three anthracycline-free taxane-based regimens, as first line chemotherapy, in metastatic breast cancer

A randomized phase III study comparing three anthracycline-free taxane-based regimens, as first line chemotherapy, in metastatic breast cancer

Induction with mitomycin C, doxorubicin, cisplatin and maintenance with weekly 5-fluorouracil, leucovorin for treatment of metastatic nasopharyngeal carcinoma: a phase II study

Fifteen-year trends in metastatic breast cancer survival in Greece

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