Tailored fluorouracil, epirubicin, and cyclophosphamide compared with marrow-supported high-dose chemotherapy as adjuvant treatment for high-risk breast cancer: a randomised trial

Bergh, Jonas; Wıklund, Tom; Erikstein, Bjørn; Lidbrink, Elisabet; Lindman, Henrik; Malmström, Per; Kellokumpu‐Lehtinen, Pirkko; Bengtsson, Nils‐Olof; Söderlund, Gustaf; Anker, Gun; Wist, Erik; Ottosson, Susanne; Salminen, Eeva; Ljungman, Per; Holte, Harald; Nilsson, Jonas; Blomqvist, Carl; Wilking, Nils

doi:10.1016/s0140-6736(00)02841-5

Cited by 234 publications

(126 citation statements)

References 27 publications

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“…In this series of 100 patients, we have observed two cases of myelodysplastic syndrome, one of which was already present before the start of HD-CT. The early MDS may be the result of epirubicin exposure, as seen in the Scandinavian trial (Bergh et al, 2000), but in the second patient the interval was too long for a relation with topo-isomerase II inhibitors. There were also four skin cancers (two of which were melanomas) and a mixed müllerian tumour of the ovary (Table 7).…”

Section: Discussionmentioning

confidence: 95%

“…The widely employed STAMP-V regimen, a combination of cyclophosphamide, thiotepa and carboplatin (CTC), has been reported to be well tolerated (Antman et al, 1992). STAMP-V has been employed in several large randomised studies in breast cancer (Bergh et al, 2000;Stadtmauer et al, 2000), none of which showed a (progression-free) survival advantage for the patients receiving this treatment.…”

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confidence: 99%

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Toxicity of the high-dose chemotherapy CTC regimen (cyclophosphamide, thiotepa, carboplatin): the Netherlands Cancer Institute experience

et al. 2003

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High-dose chemotherapy (HD-CT) has a role in the potentially curative treatment of several tumours. The relative efficacies of the different regimens have not been studied in comparative trials, but it is clear that toxicities differ significantly between them. We analysed the immediate and long-term toxicity in the first 100 consecutive patients treated with the CTC regimen (cyclophosphamide 6000 mg m À2 , carboplatin 1600 mg m À2 (or 20 mg ml À1 min under the curve (AUC)) both as daily 1 h infusion, thiotepa 480 mg m À2 as twice daily 30 min infusion, all divided over 4 consecutive days) followed by peripheral blood progenitor cell reinfusion (PBPC-Tx). Most patients had high-risk (n ¼ 86) or metastatic (n ¼ 4) breast cancer, or a germ cell tumour (n ¼ 8). Two patients (with a medulloblastoma and an aesthesioneuroblastoma, respectively) received CTC as off-protocol salvage regimen. The main toxicity was bone marrow suppression. Most patients had PBPC-Tx with granulocyte colony-stimulating factor (G-CSF), and the median time to neutrophil count 500 Â 10 6 l À1 and platelet count 420 Â 10 9 l À1 without transfusion independence was 10 (range 8 -25) and 13 (8 -60) days, respectively. The toxic death rate was 1%. Other frequent toxicities were neutropenic fever requiring antibiotics (n ¼ 65), central catheter-related infection (n ¼ 12) or a bleeding episode (n ¼ 48), mostly epistaxis (n ¼ 26). Reversible cardiac toxicity was seen in six patients and pulmonary events occurred in seven patients (infection (n ¼ 6), embolism (n ¼ 1)). Grade 3 -4 gastrointestinal toxicity was frequent: nausea and vomiting 55%, diarrhoea 28% and mild liver toxicity (transaminase elevations) 9%. One patient pretreated with cisplatin had a kidney transplantation 8 years after HD-CT. Late complications included reversible radiation pneumonitis (n ¼ 12) and chronic heart failure (n ¼ 2). We found five second solid malignancies and two myelodysplasias. In conclusion, the CTC regimen is associated with a moderate, mainly reversible, toxicity. Future studies need to compare the efficacy and toxicity of the different HD-CT regimens.

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Section: Discussionmentioning

confidence: 95%

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confidence: 99%

Toxicity of the high-dose chemotherapy CTC regimen (cyclophosphamide, thiotepa, carboplatin): the Netherlands Cancer Institute experience

et al. 2003

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“…One, the small Dutch high dose trial, did not define risk by the number of pathological nodes involved, and so comparisons with the current data set are difficult (Rodenhuis et al, 1998). The other, the interesting Swedish study of 'tailored' FEC against high dose chemotherapy, defined risk by the anticipated 5 year outcome with standard therapy (Bergh et al, 2000). This translated into including women without low-grade tumours, and either eight or more nodes when the tumour was ER positive or five or more nodes when it was ER negative.…”

Section: Clinicalmentioning

confidence: 96%

Block sequential adriamycin CMF – optimal non-myeloablative chemotherapy for high risk adjuvant breast cancer?

et al. 2002

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After the publication of the 10-year survival data from Milan on the adjuvant use of the block sequential regimen consisting of four cycles of adriamycin followed by eight cycles of intravenous CMF, many centres adopted this as standard of care for high risk, multiple node-positive breast cancer. For this reason it was identified as the standard arm for the Anglo-Celtic adjuvant high-dose chemotherapy trial. This study reports on the experience of this regimen in 329 women with early breast cancer involving at least four axillary nodes, who were treated outside any adjuvant chemotherapy trial. At a median follow-up of 3 years, the overall 5-year disease-free survival is 61%, and the overall survival is 70%. These data confirm the efficacy of this regimen in non-trial patients, and, for the same high risk subgroup, indicate that this approach offers an outcome at least as good as that seen in the CALGB 9344 AC-Taxol arm, and the NCIC days 1 and 8 CEF.

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“…In brief, tailored therapy aims to limit toxicity, improve compliance, and therefore maintain treatment for as long as possible and prolong survival. The efficacy of tailored FEC therapy (5-FU, epirubicin, and cyclophosphamide) as postoperative adjuvant chemotherapy for breast cancer has been shown [8]. In Japan, Takahashi et al administered tailored gemcitabine therapy to patients with pancreatic cancer, and found improvements in both symptoms and quality of life in 75% of subjects [9].…”

Section: Introductionmentioning

confidence: 99%

Randomized phase II trial of first-line treatment with tailored irinotecan and S-1 therapy versus S-1 monotherapy for advanced or recurrent gastric carcinoma (JFMC31-0301)

Kimura¹,

Oda²,

Tajima³

et al. 2011

Anti-Cancer Drugs

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Objective: The pharmacokinetics of irinotecan vary markedly between individuals. This study sought to compare tailored irinotecan plus S-1 therapy with S-1 monotherapy for the treatment of patients with advanced/recurrent gastric cancer. Methods:Patients with advanced/recurrent gastric cancer were randomized to receive tailored irinotecan plus S-1 (arm A) or S-1 alone (arm B). Arm A received S-1 (80−120 mg/m 2 /day) for 14 days, with irinotecan on days 1 and 15. The initial irinotecan dose of 75 mg/m 2 (Level 0) was adjusted for toxicity during the previous course. In arm B, S-1 (80−120 mg/day) was administered alone for 28 days, followed by 14 days without therapy.Results: Ninety-five patients were randomized (48 to arm A and 47 to arm B). The response rate of the primary tumor (Japanese criteria) was 25.0% in arm A (12/48) and 14.9% in arm B (7/47), while the response rates according to Response Evaluation Criteria In Solid Tumors (RECIST) were 27.8% (10/36) versus 21.9% (7/32).Hematological toxicity, anorexia, and diarrhea were significantly more common in arm A, but both arms had similar grade 3−4 toxicities. Conclusion:These findings suggest the usefulness of tailored irinotecan plus S-1 therapy for gastric cancer.

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Tailored fluorouracil, epirubicin, and cyclophosphamide compared with marrow-supported high-dose chemotherapy as adjuvant treatment for high-risk breast cancer: a randomised trial

Cited by 234 publications

References 27 publications

Toxicity of the high-dose chemotherapy CTC regimen (cyclophosphamide, thiotepa, carboplatin): the Netherlands Cancer Institute experience

Toxicity of the high-dose chemotherapy CTC regimen (cyclophosphamide, thiotepa, carboplatin): the Netherlands Cancer Institute experience

Block sequential adriamycin CMF – optimal non-myeloablative chemotherapy for high risk adjuvant breast cancer?

Randomized phase II trial of first-line treatment with tailored irinotecan and S-1 therapy versus S-1 monotherapy for advanced or recurrent gastric carcinoma (JFMC31-0301)

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