HER2 Support Group Forums - View Single Post - Tykerb Lung Breathing reaction

Jackie07 · 11-14-2013, 12:28 AM

Hi,

You might have already seen it. This study 3 1/2 years ago put it at 2 in 1000:

Ann Oncol. 2010 Mar;21(3):474-80. doi: 10.1093/annonc/mdp373. Epub 2009 Oct 8.
An open-label expanded access study of lapatinib and capecitabine in patients with HER2-overexpressing locally advanced or metastatic breast cancer.
Capri G, Chang J, Chen SC, Conte P, Cwiertka K, Jerusalem G, Jiang Z, Johnston S, Kaufman B, Link J, Ro J, Schütte J, Oliva C, Parikh R, Preston A, Rosenlund J, Selzer M, Zembryki D, De Placido S.
Source
Department of Medical Oncology, Fondazione IRCCS Istituto Tumori, Milano, Italy. giuseppe.capri@istitutotumori.mi.it
Abstract
BACKGROUND:
The Lapatinib Expanded Access Program (LEAP) was designed to provide access to lapatinib plus capecitabine for HER2-positive metastatic breast cancer patients who previously received an anthracycline, a taxane, and a trastuzumab and had no other treatment options.
PATIENTS AND METHODS:
LEAP opened globally and enrollment continued until lapatinib received regulatory approval in each participating country. Patients were assessed for progression-free survival (PFS) and overall survival (OS) and monitored for serious adverse events (SAEs).
RESULTS:
As of 30 September 2008, 4283 patients from 45 countries enrolled in LEAP. The median treatment duration was 24.7 weeks. The most common drug-related SAEs were diarrhea (9.7%), vomiting (4.3%), and nausea (2.4%) and were mainly grade 3 or higher. The incidences of special interest SAEs were decreased left ventricle ejection fraction (0.5%), interstitial lung disease/pneumonitis (0.2%), and serious hepatobiliary events (0.4%). This safety profile is consistent with the overall lapatinib program. The median PFS and OS were 21.1 [95% confidence interval (CI) = 20.1-22.3] and 39.6 (95% CI = 37.7-40.7) weeks, respectively (n = 4006). Subgroup analysis showed longer PFS and OS in patients who had not received prior capecitabine.
CONCLUSIONS:
These results demonstrate the safety and efficacy of lapatinib in a broader patient population compared with a clinical trial.

11-14-2013, 12:28 AM	#2
Jackie07 Senior Member Join Date: Jan 2008 Location: "Love never fails." Posts: 5,808	Re: Tykerb Lung Breathing reaction - HELP Hi, You might have already seen it. This study 3 1/2 years ago put it at 2 in 1000: Ann Oncol. 2010 Mar;21(3):474-80. doi: 10.1093/annonc/mdp373. Epub 2009 Oct 8. An open-label expanded access study of lapatinib and capecitabine in patients with HER2-overexpressing locally advanced or metastatic breast cancer. Capri G, Chang J, Chen SC, Conte P, Cwiertka K, Jerusalem G, Jiang Z, Johnston S, Kaufman B, Link J, Ro J, Schütte J, Oliva C, Parikh R, Preston A, Rosenlund J, Selzer M, Zembryki D, De Placido S. Source Department of Medical Oncology, Fondazione IRCCS Istituto Tumori, Milano, Italy. giuseppe.capri@istitutotumori.mi.it Abstract BACKGROUND: The Lapatinib Expanded Access Program (LEAP) was designed to provide access to lapatinib plus capecitabine for HER2-positive metastatic breast cancer patients who previously received an anthracycline, a taxane, and a trastuzumab and had no other treatment options. PATIENTS AND METHODS: LEAP opened globally and enrollment continued until lapatinib received regulatory approval in each participating country. Patients were assessed for progression-free survival (PFS) and overall survival (OS) and monitored for serious adverse events (SAEs). RESULTS: As of 30 September 2008, 4283 patients from 45 countries enrolled in LEAP. The median treatment duration was 24.7 weeks. The most common drug-related SAEs were diarrhea (9.7%), vomiting (4.3%), and nausea (2.4%) and were mainly grade 3 or higher. The incidences of special interest SAEs were decreased left ventricle ejection fraction (0.5%), interstitial lung disease/pneumonitis (0.2%), and serious hepatobiliary events (0.4%). This safety profile is consistent with the overall lapatinib program. The median PFS and OS were 21.1 [95% confidence interval (CI) = 20.1-22.3] and 39.6 (95% CI = 37.7-40.7) weeks, respectively (n = 4006). Subgroup analysis showed longer PFS and OS in patients who had not received prior capecitabine. CONCLUSIONS: These results demonstrate the safety and efficacy of lapatinib in a broader patient population compared with a clinical trial. __________________ Jackie07 http://www.kevinmd.com/blog/2011/06/doctors-letter-patient-newly-diagnosed-cancer.html http://www.asco.org/ASCOv2/MultiMedi...=114&trackID=2 NICU 4.4 LB Erythema Nodosum 85 Life-long Central Neurocytoma 4x5x6.5 cm 23 hrs 62090 semi-coma 10 d PT OT ST 30 d 3 Infertility tmts 99 > 3 u. fibroids > Pills CN 3 GKRS 52301 IDC 1.2 cm Her2 +++ ER 5% R. Lmptmy SLNB+1 71703 6 FEC 33 R Tamoxifen Recc IIB 2.5 cm Bi-L Mast 61407 2/9 nds PET 6 TCH Cellulitis - Lymphedema - compression sleeve & glove H w x 4 MUGA 51 D, J 49 M Diastasis recti Tamoxifen B. scan Irrtbl bowel 1'09 Colonoscopy 313 BRCA1 V1247I hptc hemangioma Vertigo GI - > yogurt hysterectomy/oophorectomy 011410 Exemestane 25 mg tab 102912 ~ 101016 stopped due to r. hip/l.thigh pain after long walk DEXA 1/13 1-2016 lesions in liver largest 9mm & 1.3 cm onco. says not cancer. 3-11 Appendectomy - visually O.K., a lot of puss. Final path result - not cancer. Start Vitamin D3 and Calcium supplement （600mg x2) 10-10 Stopped Exemestane due to r. hip/l.thigh pain OKed by Onco 11-08-2016 7-23-2018 9 mm groundglass nodule within the right lower lobe with indolent behavior. Due to possible adenocarcinoma, Recommend annual surveilence. 7-10-2019 CT to check lung nodule. 1-10-2020 8mm stable nodule on R Lung, two 6mm new ones on L Lung, a possible lymph node involvement in inter fissule. "I WANT TO BE AN OUTRAGEOUS OLD WOMAN WHO NEVER GETS CALLED AN OLD LADY. I WANT TO GET SHARP EDGED & EARTH COLORED, TILL I FADE AWAY FROM PURE JOY." Irene from Tampa Advocacy is a passion .. not a pastime - Joe Last edited by Jackie07; 11-19-2013 at 04:55 AM..