Abstract | BACKGROUND: Dual anti-HER2 therapy is effective for HER2-amplified breast cancer. Weekly paclitaxel, trastuzumab, and full-dose lapatinib (PTL) is not feasible because of grade 3 diarrhea. We conducted a phase II feasibility study of dose-dense (DD; every other week) PTL (ClinicalTrials.gov identifier, NCT01827163). PATIENTS AND METHODS: RESULTS: From May 2013 to November 2013, we enrolled 20 of 55 planned patients. The median age was 49 years (range, 34-74 years). One patient had immediate paclitaxel hypersensitivity and was deemed inevaluable. Only 13 of 19 evaluable patients (68%) completed PTL without a dose delay or reduction or unacceptable toxicities. Only 3 of 19 (16%) had grade 3 diarrhea. Rash was frequent, with all grades in 18 of 19 (95%) and grade 3 in 2 of 19 (11%). The study was stopped early because of excess toxicity. CONCLUSION: The discontinuation rate during DD PTL was high, owing, in part, to an unexpectedly high incidence of rash. The trial was halted, because the initial discontinuation rate from overall toxicity made it unlikely that full accrual would demonstrate feasibility.
|
Authors | Neil M Iyengar, Monica N Fornier, Steven M Sugarman, Maria Theodoulou, Tiffany A Troso-Sandoval, Gabriella M D'Andrea, Pamela R Drullinsky, Devika Gajria, Shari B Goldfarb, Elizabeth A Comen, Diana E Lake, Shanu Modi, Tiffany A Traina, Mario E Lacouture, Melanie F Chen, Sujata Patil, José Baselga, Larry Norton, Clifford A Hudis, Chau T Dang |
Journal | Clinical breast cancer
(Clin Breast Cancer)
Vol. 16
Issue 2
Pg. 87-94
(Apr 2016)
ISSN: 1938-0666 [Electronic] United States |
PMID | 26454612
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
|
Copyright | Copyright © 2016 Elsevier Inc. All rights reserved. |
Chemical References |
- Biomarkers, Tumor
- Quinazolines
- Receptors, Estrogen
- Receptors, Progesterone
- Lapatinib
- ERBB2 protein, human
- Receptor, ErbB-2
- Trastuzumab
- Paclitaxel
|
Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Biomarkers, Tumor
(metabolism)
- Breast Neoplasms
(drug therapy, metabolism, pathology)
- Dose-Response Relationship, Drug
- Feasibility Studies
- Female
- Follow-Up Studies
- Humans
- Immunoenzyme Techniques
- Lapatinib
- Middle Aged
- Neoplasm Recurrence, Local
(drug therapy, metabolism, pathology)
- Neoplasm Staging
- Paclitaxel
(administration & dosage)
- Pilot Projects
- Prognosis
- Quinazolines
(administration & dosage)
- Receptor, ErbB-2
(metabolism)
- Receptors, Estrogen
(metabolism)
- Receptors, Progesterone
(metabolism)
- Trastuzumab
(administration & dosage)
|
|
Join CureHunter, for free Research Interface BASIC access!
Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease.
Find out why thousands of doctors, pharma researchers and patient activists
around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!
|