Multicenter Phase II Trial of Weekly Paclitaxel in Women With Metastatic Breast Cancer

Perez, Edith A.; Vogel, Charles L.; Irwin, David; Kirshner, Jeffrey J.; Patel, Ravi

doi:10.1200/jco.2001.19.22.4216

Cited by 238 publications

(177 citation statements)

References 16 publications

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“…In our series, the med ian survival fro m the diagnosis of metastasis was 3 years, comparable with recently published series reporting a median survival in the 1,5 to 3.5 years range [20][21]. The median survival, counting fro m CT3 was 13 months, comparable to the pactlitaxel trial after failure of two anthracycline and taxane line [22][23].Our analysis also recalled the efficacy of taxane chemotherapy, even in patients who had had prior treat ments [24]. Surv ival rates differed fro m CT3 between the NPD and PD groups.…”

Section: Discussionsupporting

confidence: 87%

“…Therapeutic protocols, especially those using new compounds, generally exclude patients who have already received two lines of chemotherapy. There have nevertheless been a few phase II and III trials which have included CT3 patients [25,32] in order to assess the efficacy and safety of new drugs. Elsewhere, treat ments proposed for patients with metastatic disease are generally grouped together (chemotherapy, hormone therapy, both) with a med ian of 3 different lines of treatment [33].…”

Section: Discussionmentioning

confidence: 99%

“…In the present state of the art, it is difficult to choose a treatment on the basis of prognostic factors determined for CT1. Data in the literature fail to provide any insight for CT3 since the majority of the published trials devoted to CT2 were small-scale, non-comparative, and limited, evaluating only the feasibility of monotherapy or a combination of several cytotoxic agents used in a phase II setting in patients with a very good general status [55,58,59,60,61].…”

Section: Discussionmentioning

confidence: 99%

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Usefulness of chemotherapy beyond the second line for metastatic breast cancer: a therapeutic challenge

Vauléon

Mesbah

Laguerre³

et al. 2009

Cancer Chemother Pharmacol

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To cite this version:Elodie Purpose: Several lines of chemotherapy can be proposed for patients with metastatic breast cancer, but beyond the second line, agreement is lacking concerning the most appropriate therapeutic strategy. Methods:We conducted a retrospective analysis of the files of 162 patients, who had received at least three lines of chemotherapy (CT3) for metastatic breast cancer during a 5-year period (2000 to 2004), in order to analy ze management practices and search for factors affecting survival fro m CT3 and predictive factors of nonprogressive disease after CT3.Results: Multivariate analysis identified seven factors which had a positive influence on survival fro m CT3 (SBR grade I, absence of adjuvant hormone therapy, free interval ≥ 2 years, absence of cerebromeningeal metastasis before CT, unique focus at initiat ion of CT3, use of polychemotherapy for CT2, and comp lete res ponse to CT1 or CT2) and two predict ive factors of non-progressive disease (histology and drug group used for CT3).Conclusions: These factors should help determine the appropriate strategy for proposing a third line of chemotherapy.. .

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Section: Discussionsupporting

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Usefulness of chemotherapy beyond the second line for metastatic breast cancer: a therapeutic challenge

Vauléon

Mesbah

Laguerre³

et al. 2009

Cancer Chemother Pharmacol

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“…The combination of weekly paclitaxel with trastuzumab [10,15,16] produces extended cumulative exposure to the drug and ameliorates the toxicities associated with the standard tri-weekly administration [17], with mild, non-cumulative, hematologic toxicity allowing its administration for prolonged periods of time [18].…”

Section: Introductionmentioning

confidence: 99%

Randomized Phase II Trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with Her-2 positive advanced breast cancer

Gasparini

Gion²,

Mariani³

et al. 2006

Breast Cancer Res Treat

129

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Background A randomized Phase II study evaluated the activity of weekly paclitaxel versus its combination with trastuzumab for treatment of patients with advanced breast cancer overexpressing HER-2. Patients and methods Among 124 patients randomized, 123 are assessable for toxicity and 118 for response. Patients received weekly paclitaxel single agent (80 mg/m 2 ) or combined with trastuzumab (4 mg/kg loading dose, then weekly 2 mg/kg). HER-2 overexpression was determined by immunohistochemistry (IHC). Patients with 2+/3+ IHC scores were eligible. IHC was compared with HER-2 serum extracellular domain (ECD). Results Patient characteristics were similar in the two arms. Both treatments were feasible and well tolerated with no grade 4 hematologic toxicity. No patient developed cardiac toxicity. The combined treatment was statistically significant superior for overall response rate (ORR) (75% vs. 56.9%; P = 0.037), particularly in the subset of IHC 3+ patients (84.5% vs. 47.5%; P = 0.00050). A statistically significant better median time to progression was seen in the subgroup with IHC 3+ (369 vs. 272 days; P = 0.030) and visceral disease (301 vs. 183 days; P = 0.0080) treated with combination. Multivariable analysis of predictive factors showed that only IHC score retained statistically significant value for ORR (P = 0.0035). Conclusion Weekly paclitaxel plus trastuzumab is highly active and safe and it is superior to paclitaxel alone in patients with IHC score of 3+.

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“…72,73 If disclosure of research results is sought by investigators, then institutional review board approval must be obtained, and such results should be disclosed by a clinician or investigator who is competent to discuss any clinical implications with the recipient at that time. 74 …”

Section: Issue 4: Previously Unidentified Health Risks Uncovered As Amentioning

confidence: 99%

Ethical aspects of participation in the Database of Genotypes and Phenotypes of the National Center for Biotechnology Information

Peppercorn

Shapira

Deshields

et al. 2012

Cancer

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BACKGROUND: The rapid pace of genetics research, coupled with evolving standards for informed consent, can create ethical challenges regarding future use of tissue or information from completed clinical trials. The Cancer and Leukemia Group B (CALGB) Oncology Cooperative Group was faced with an ethical dilemma regarding sharing genetic data from a completed genome‐wide association study (GWAS) that was conducted as part of a large, multicenter breast cancer clinical trial with a national database: the Database of Genotypes and Phenotypes National Center for Biotechnology Information (dbGaP). METHODS: The CALGB Ethics Committee conducted a series of multidisciplinary meetings and teleconferences involving patient advocates, bioethicists, clinical researchers, and clinical oncologists to evaluate the ethical issues raised by this case and to identify lessons for improving informed consent to future genetics research in oncology trials. RESULTS: The Ethics Committee recommended that GWAS data be provided to dbGaP consistent with documented consent for future use of tissue among trial participants. Ethical issues, including adequacy of informed consent to future research, limitations of privacy in modern genetics research, the potential impact of population‐based genetics research on health disparities, and recontact of research participants for clinical care or further research, were identified as major ethical considerations in this area. CONCLUSIONS: Although modern standards for informed consent should not prohibit research or sharing of data consistent with participant's intent and the public interest, there is an urgent need for national consensus on the appropriate use of archived tissue and standardized informed consent for future research among cancer clinical trial participants. Cancer 2012. © 2012 American Cancer Society.

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Multicenter Phase II Trial of Weekly Paclitaxel in Women With Metastatic Breast Cancer

Abstract: Weekly paclitaxel therapy was well tolerated and demonstrated reasonable activity in this relatively heavily pretreated population with advanced disease. Further study of weekly paclitaxel in combination therapy is warranted.

Cited by 238 publications

References 16 publications

Usefulness of chemotherapy beyond the second line for metastatic breast cancer: a therapeutic challenge

Usefulness of chemotherapy beyond the second line for metastatic breast cancer: a therapeutic challenge

Randomized Phase II Trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with Her-2 positive advanced breast cancer

Ethical aspects of participation in the Database of Genotypes and Phenotypes of the National Center for Biotechnology Information

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