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Phase I trial of sequential high-dose chemotherapy with escalating dose paclitaxel, melphalan, and cyclophosphamide, thiotepa, and carboplatin with peripheral blood progenitor support in women with responding metastatic breast cancer.
Clin Cancer Res. 1998 Jul; 4(7):1689-95.CC

Abstract

A single high-dose cycle of chemotherapy with stem cell support can produce disease-free survival of 15-20% for at least 3 years in women with responding stage IV breast cancer. North American Autologous Bone Marrow Transplant Registry data suggest that a complete response (CR) is the single most important prognostic factor associated with prolonged disease-free survival. Therefore, if sequential high-dose chemotherapy can increase the CR rate, then perhaps an increased proportion of patients will remain disease free. Women with at least a partial response (PR) to induction chemotherapy received three separate high-dose cycles of chemotherapy with peripheral blood progenitor support and granulocyte colony-stimulating factor. The first intensification was a dose escalation of paclitaxel (400-825 mg/ m2), the second intensification was melphalan (180 mg/m2), and the third intensification consisted of 6000 mg/m2 cyclophosphamide (1500 mg/m2/day), 500 mg/m2 thiotepa (125 mg/m2/day), and 800 mg/m2 carboplatin (200 mg/m2/day; CTCb). Thirty-six women were enrolled and 31 completed all three cycles. After the paclitaxel infusion most patients developed reversible predominantly sensory neuropathy. Of the 19 patients with measurable disease, 6 converted to CR, 7 converted to a PR* (the complete resolution of all soft tissue or visceral disease with sclerosis of prior lytic bone lesions), and 2 had a further PR for an overall response rate of 79%. Two patients had no further response and disease in two patients progressed, and thus they were taken off the study before CTCb. Seventy-eight percent are progression-free at a median follow-up of 14 months (range, 3-24+). Three sequential cycles of high-dose chemotherapy are feasible and were administered in this study with no mortality. Single agent paclitaxel at doses up to 825 mg/m2 were well tolerated with moderate reversible toxicity.

Authors+Show Affiliations

Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York 10032, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase I
Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

9676843

Citation

Vahdat, L T., et al. "Phase I Trial of Sequential High-dose Chemotherapy With Escalating Dose Paclitaxel, Melphalan, and Cyclophosphamide, Thiotepa, and Carboplatin With Peripheral Blood Progenitor Support in Women With Responding Metastatic Breast Cancer." Clinical Cancer Research : an Official Journal of the American Association for Cancer Research, vol. 4, no. 7, 1998, pp. 1689-95.
Vahdat LT, Papadopoulos K, Balmaceda C, et al. Phase I trial of sequential high-dose chemotherapy with escalating dose paclitaxel, melphalan, and cyclophosphamide, thiotepa, and carboplatin with peripheral blood progenitor support in women with responding metastatic breast cancer. Clin Cancer Res. 1998;4(7):1689-95.
Vahdat, L. T., Papadopoulos, K., Balmaceda, C., McGovern, T., Dunleavy, J., Kaufman, E., Fung, B., Garrett, T., Savage, D., Tiersten, A., Ayello, J., Bagiella, E., Heitjan, D., Antman, K., & Hesdorffer, C. (1998). Phase I trial of sequential high-dose chemotherapy with escalating dose paclitaxel, melphalan, and cyclophosphamide, thiotepa, and carboplatin with peripheral blood progenitor support in women with responding metastatic breast cancer. Clinical Cancer Research : an Official Journal of the American Association for Cancer Research, 4(7), 1689-95.
Vahdat LT, et al. Phase I Trial of Sequential High-dose Chemotherapy With Escalating Dose Paclitaxel, Melphalan, and Cyclophosphamide, Thiotepa, and Carboplatin With Peripheral Blood Progenitor Support in Women With Responding Metastatic Breast Cancer. Clin Cancer Res. 1998;4(7):1689-95. PubMed PMID: 9676843.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase I trial of sequential high-dose chemotherapy with escalating dose paclitaxel, melphalan, and cyclophosphamide, thiotepa, and carboplatin with peripheral blood progenitor support in women with responding metastatic breast cancer. AU - Vahdat,L T, AU - Papadopoulos,K, AU - Balmaceda,C, AU - McGovern,T, AU - Dunleavy,J, AU - Kaufman,E, AU - Fung,B, AU - Garrett,T, AU - Savage,D, AU - Tiersten,A, AU - Ayello,J, AU - Bagiella,E, AU - Heitjan,D, AU - Antman,K, AU - Hesdorffer,C, PY - 1998/7/24/pubmed PY - 1998/7/24/medline PY - 1998/7/24/entrez SP - 1689 EP - 95 JF - Clinical cancer research : an official journal of the American Association for Cancer Research JO - Clin Cancer Res VL - 4 IS - 7 N2 - A single high-dose cycle of chemotherapy with stem cell support can produce disease-free survival of 15-20% for at least 3 years in women with responding stage IV breast cancer. North American Autologous Bone Marrow Transplant Registry data suggest that a complete response (CR) is the single most important prognostic factor associated with prolonged disease-free survival. Therefore, if sequential high-dose chemotherapy can increase the CR rate, then perhaps an increased proportion of patients will remain disease free. Women with at least a partial response (PR) to induction chemotherapy received three separate high-dose cycles of chemotherapy with peripheral blood progenitor support and granulocyte colony-stimulating factor. The first intensification was a dose escalation of paclitaxel (400-825 mg/ m2), the second intensification was melphalan (180 mg/m2), and the third intensification consisted of 6000 mg/m2 cyclophosphamide (1500 mg/m2/day), 500 mg/m2 thiotepa (125 mg/m2/day), and 800 mg/m2 carboplatin (200 mg/m2/day; CTCb). Thirty-six women were enrolled and 31 completed all three cycles. After the paclitaxel infusion most patients developed reversible predominantly sensory neuropathy. Of the 19 patients with measurable disease, 6 converted to CR, 7 converted to a PR* (the complete resolution of all soft tissue or visceral disease with sclerosis of prior lytic bone lesions), and 2 had a further PR for an overall response rate of 79%. Two patients had no further response and disease in two patients progressed, and thus they were taken off the study before CTCb. Seventy-eight percent are progression-free at a median follow-up of 14 months (range, 3-24+). Three sequential cycles of high-dose chemotherapy are feasible and were administered in this study with no mortality. Single agent paclitaxel at doses up to 825 mg/m2 were well tolerated with moderate reversible toxicity. SN - 1078-0432 UR - https://www.unboundmedicine.com/medline/citation/9676843/Phase_I_trial_of_sequential_high_dose_chemotherapy_with_escalating_dose_paclitaxel_melphalan_and_cyclophosphamide_thiotepa_and_carboplatin_with_peripheral_blood_progenitor_support_in_women_with_responding_metastatic_breast_cancer_ L2 - http://clincancerres.aacrjournals.org/cgi/pmidlookup?view=long&pmid=9676843 DB - PRIME DP - Unbound Medicine ER -