PMID- 18458039 OWN - NLM STAT- MEDLINE DCOM- 20080708 LR - 20181201 IS - 1527-7755 (Electronic) IS - 0732-183X (Linking) VI - 26 IP - 18 DP - 2008 Jun 20 TI - Efficacy and safety of lapatinib as first-line therapy for ErbB2-amplified locally advanced or metastatic breast cancer. PG - 2999-3005 LID - 10.1200/JCO.2007.14.0590 [doi] AB - PURPOSE: This study (EGF20009) assessed the efficacy and tolerability of two lapatinib administration schedules as first-line monotherapy in women with ErbB2-amplified locally advanced or metastatic breast cancer. PATIENTS AND METHODS: Patients with ErbB2-amplified, locally advanced or metastatic breast cancer previously untreated in the metastatic setting were randomly assigned to one of two lapatinib dose cohorts and received either 1,500 mg once daily or 500 mg twice daily. Clinical response was assessed at weeks 8 and 12 and every 12 weeks thereafter. RESULTS: A total of 138 patients were treated with lapatinib for a median of 17.6 weeks. The overall response rate (complete response [CR] plus partial response [PR]) was 24% in the intent-to-treat population, and 31% of patients derived clinical benefit (CR, PR, or stable disease for >or= 24 weeks). The median time to response was 7.9 weeks, and the progression-free survival rates at 4 and 6 months were 63% and 43%, respectively. The most common lapatinib-related adverse events (AEs) were diarrhea, rash, pruritus, and nausea, and these events were primarily grade 1 or 2. There were no significant differences in clinical activity or the AE profile between the dosing schedules. CONCLUSION: Lapatinib demonstrated clinical activity and was well tolerated as first-line therapy in ErbB2-amplified locally advanced or metastatic breast cancer. This study supports further evaluation of lapatinib in first-line and early-stage ErbB2-overexpressing breast cancer. FAU - Gomez, Henry L AU - Gomez HL AD - Instituto Nacional de Enfermedades Neoplasicas, Hospital Alberto Sabogal, Lima, Peru. hgomez@inen.sld.pe FAU - Doval, Dinesh C AU - Doval DC FAU - Chavez, Miguel A AU - Chavez MA FAU - Ang, Peter C-S AU - Ang PC FAU - Aziz, Zeba AU - Aziz Z FAU - Nag, Shona AU - Nag S FAU - Ng, Christina AU - Ng C FAU - Franco, Sandra X AU - Franco SX FAU - Chow, Louis W C AU - Chow LW FAU - Arbushites, Michael C AU - Arbushites MC FAU - Casey, Michelle A AU - Casey MA FAU - Berger, Mark S AU - Berger MS FAU - Stein, Steven H AU - Stein SH FAU - Sledge, George W AU - Sledge GW LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20080505 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Antineoplastic Agents) RN - 0 (Protein Kinase Inhibitors) RN - 0 (Quinazolines) RN - 0VUA21238F (Lapatinib) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM CIN - J Clin Oncol. 2008 Jun 20;26(18):2940-2. PMID: 18458041 CIN - J Clin Oncol. 2009 Jan 10;27(2):314-5; author reply 315-7. PMID: 19064955 MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/*administration & dosage/adverse effects MH - Breast Neoplasms/*drug therapy/*enzymology MH - Disease-Free Survival MH - Drug Administration Schedule MH - Female MH - Humans MH - Lapatinib MH - Middle Aged MH - Neoplasm Metastasis MH - Protein Kinase Inhibitors/administration & dosage/adverse effects MH - Quinazolines/*administration & dosage/adverse effects MH - Receptor, ErbB-2/antagonists & inhibitors/*biosynthesis EDAT- 2008/05/07 09:00 MHDA- 2008/07/09 09:00 CRDT- 2008/05/07 09:00 PHST- 2008/05/07 09:00 [pubmed] PHST- 2008/07/09 09:00 [medline] PHST- 2008/05/07 09:00 [entrez] AID - JCO.2007.14.0590 [pii] AID - 10.1200/JCO.2007.14.0590 [doi] PST - ppublish SO - J Clin Oncol. 2008 Jun 20;26(18):2999-3005. doi: 10.1200/JCO.2007.14.0590. Epub 2008 May 5.