Adenocarcinoma ; drug therapy ; Antibodies, Monoclonal ; adverse effects ; Drug Resistance, Neoplasm ; Female ; Fever ; chemically induced ; Humans ; Liver Neoplasms ; secondary ; Lung Neoplasms ; drug therapy ; Middle Aged ; Quinazolines ; therapeutic use

BACKGROUNDThe preclinical experiments and several clinical studies showed icotinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in Chinese patients with advanced non-small cell lung cancer (NSCLC) who failed previous chemotherapy. We performed a retrospective study of the efficacy and safety of icotinib monotherapy in a different and more recent sample of Chinese patients.

METHODSThe clinical data of 149 patients with advanced NSCLC who were admitted to Zhejiang Cancer Hospital from August 1, 2011 to July 31, 2012 were retrospectively analyzed. All patients were given icotinib treatment after the failure of previous chemotherapy. Univariate and multivariate analyses were conducted based on the Kaplan Meier method and Cox proportional hazards model.

RESULTSThe objective response rate was 33/149 and disease control rate was 105/149. No complete response occurred. Median progression free survival (PFS) with icotinib treatment was 5.03 months (95% CI: 3.51 to 6.55). Median overall survival was 12.3 months (95% CI: 10.68 to 13.92). Multivariate analysis showed that the mutation of EGFR and one regimen of prior chemotherapy were significantly associated with longer PFS. At least one drug related adverse event was observed in 65.8% (98/149) of patients, but mostly grade 1 or 2 and reversible and none grade 4 toxicity.

CONCLUSIONSIcotinib monotherapy is an effective and well tolerated regimen for Chinese patients with NSCLC after the failure of chemotherapy. It is a promising agent and further study with icotinib in properly conducted trials with larger patient samples and other ethnic groups is warranted.

Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; Crown Ethers ; adverse effects ; therapeutic use ; Female ; Humans ; Lung Neoplasms ; drug therapy ; Male ; Middle Aged ; Multivariate Analysis ; Proportional Hazards Models ; Quinazolines ; adverse effects ; therapeutic use ; Retrospective Studies

OBJECTIVETo observe the curative and adverse side effects of erlotinib in elderly patients with advanced non-small cell lung cancer (NSCLC).

METHODSSeven-two elderly patients with pathologically confirmed NSCLC in advanced stage (III or IV) received treatment with oral erlotinib at the daily dose of 150 mg, and the treatment was discontinued until intolerance of the side effects or the occurrence of disease progression. The clinical effect and adverse side effects of erlotinib were further observed, and the association between clinical characteristics and the response to erlotinib was also analyzed.

RESULTSAmong the 72 patients, 1 patient achieved complete remission, 8 patients had partial remission, 10 had stable disease, and 7 had progressive disease, with a disease control rate of 72.22%. After a median follow-up time of 17 months (4 to 32 months), the median survival time was 14.5 months (6.5-28.3 months), and the median time to progression was 10.6 months (5-16.5 months). Erlotinib resulted in a significantly higher rate of favorable response in female, non-smoking patients with adenocarcinoma than in male, smoking patients with squamous carcinoma (P<0.05). The occurrence of skin rash was not associated with the response to erlotinib in these patients (P>0.05). The most common drug-related adverse events included skin rash, diarrhea, hepatic dysfunction (GPT elevation), nausea and vomiting, but mostly mild and well tolerable.

CONCLUSIONErlotinib is safe and effective in the treatment of elderly patients with advanced NSCLC.

Adenocarcinoma ; drug therapy ; Aged ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; pathology ; Carcinoma, Squamous Cell ; drug therapy ; Disease-Free Survival ; Erlotinib Hydrochloride ; Female ; Humans ; Lung Neoplasms ; drug therapy ; pathology ; Male ; Neoplasm Staging ; Quinazolines ; adverse effects ; therapeutic use

OBJECTIVETo explore the efficacy and side effects of icotinib hydrochloride in the treatment of patients with advanced non-small cell lung cancer (NSCLC).

METHODSThe efficacy and side effects of icotinib hydrochloride in treatment of 59 cases with stage IV NSCIC and followed-up from March 2009 to January 2012 were retrospectively analyzed.

RESULTSTwenty seven patients (45.8%) showed partial response (PR), 17 patients (28.8%) achieved SD, and 15 (25.4%) had progressive disease. The objective response rate (ORR) was 45.8% (27/59), and disease control rate (DCR) was 74.6% (44/59). Among the 23 patients with EGFR mutation, ORR was 73.9% (17/23), and DCR was 95.7% (22/23). Thirty six patients (61.0%) achieved remission of symptoms to varying degrees. The main symptoms relieved were cough, asthmatic suffocating, pain and hoarseness. The major adverse events were mild skin rash (35.6%) and diarrhea (15.3%). Others were dry skin, nausea and stomach problems. The efficacy of icotinib hydrochloride were related to the ECOG performance status, smoking history, EGFR mutation and rash significantly (P < 0.05).

CONCLUSIONSMonotherapy with icotinib hydrochloride is effective and tolerable for patients with advanced NSCLC, especially with EGFR mutation.

Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; genetics ; pathology ; Crown Ethers ; adverse effects ; therapeutic use ; Diarrhea ; chemically induced ; Disease Progression ; Exanthema ; chemically induced ; Exons ; Female ; Follow-Up Studies ; Humans ; Lung Neoplasms ; drug therapy ; genetics ; pathology ; Male ; Middle Aged ; Mutation ; Neoplasm Staging ; Quinazolines ; adverse effects ; therapeutic use ; Receptor, Epidermal Growth Factor ; genetics ; Remission Induction ; Retrospective Studies ; Survival Rate

The present case is a patient with advanced non-small cell lung cancer (NSCLC) who developed leukoencephalopathy following radiotherapy and gefitinib treatments. There are rarely reports of such incidences because the median survival period of advanced NSCLC is only ten months. The features of leukoencephalopathy in this case were atypical for radiation leukoencephalopathy, so it was suspected that the leukoencephalopathy was associated with gefitinib.
Carcinoma, Non-Small-Cell Lung ; drug therapy ; Female ; Humans ; Leukoencephalopathies ; chemically induced ; diagnosis ; Lung Neoplasms ; drug therapy ; Middle Aged ; Quinazolines ; adverse effects ; therapeutic use

Erlotinib is accepted as a standard second-line chemotherapeutic agent in patients with non-small cell lung cancer who are refractory or resistant to first-line platinum-based chemotherapy. There has been no previous report of bowel perforation with or without gastrointestinal metastases related to erlotinib in patients with non-small cell lung cancer. The exact mechanism of bowel perforation in patients who received erlotinib remains unclear. In this report, we report the first case of enterocutaneous fistula in a female patient with metastatic non-small cell lung cancer 9 months, following medication with erlotinib as second-line chemotherapy.
Aged ; Antineoplastic Agents/*adverse effects/therapeutic use ; Carcinoma, Non-Small-Cell Lung/complications/*drug therapy ; Female ; Humans ; Intestinal Fistula/*chemically induced/complications/radiography/surgery ; Intestinal Perforation/*chemically induced/complications/radiography/surgery ; Protein Kinase Inhibitors/*adverse effects/therapeutic use ; Quinazolines/*adverse effects/therapeutic use ; Sigmoid Diseases/*chemically induced/complications/radiography/surgery

Overexpression of human epidermal growth factor receptor-2 (HER2) in metastatic breast cancer (MBC) is associated with poor prognosis. This single-arm open-label trial (EGF109491; NCT00508274) was designed to confirm the efficacy and safety of lapatinib in combination with capecitabine in 52 heavily pretreated Chinese patients with HER2-positive MBC. The primary endpoint was clinical benefit rate (CBR). Secondary endpoints included progression-free survival (PFS), time to response (TTR), duration of response (DoR), central nervous system (CNS) as first site of relapse, and safety. The results showed that there were 23 patients with partial responses and 7 patients with stable disease, resulting in a CBR of 57.7%. The median PFS was 6.34 months (95% confidence interval, 4.93-9.82 months). The median TTR and DoR were 4.07 months (range, 0.03-14.78 months) and 6.93 months (range, 1.45-9.72 months), respectively. Thirteen (25.0%) patients had new lesions as disease progression. Among them, 2 (3.8%) patients had CNS disease reported as the first relapse. The most common toxicities were palmar-plantar erythrodysesthesia (59.6%), diarrhea (48.1%), rash (48.1%), hyperbilirubinemia (34.6%), and fatigue (30.8%). Exploratory analyses of oncogenic mutations of PIK3CA suggested that of 38 patients providing a tumor sample, baseline PIK3CA mutation status was not associated with CBR (P = 0.639) or PFS (P = 0.989). These data confirm that the lapatinib plus capecitabine combination is an effective and well-tolerated treatment option for Chinese women with heavily pretreated MBC, irrespective of PIK3CA status.
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Asian Continental Ancestry Group ; Breast Neoplasms ; drug therapy ; genetics ; metabolism ; pathology ; Capecitabine ; Class I Phosphatidylinositol 3-Kinases ; Deoxycytidine ; administration & dosage ; adverse effects ; analogs & derivatives ; Diarrhea ; chemically induced ; Disease Progression ; Disease-Free Survival ; Exanthema ; chemically induced ; Female ; Fluorouracil ; administration & dosage ; adverse effects ; analogs & derivatives ; Hand-Foot Syndrome ; etiology ; Humans ; Middle Aged ; Mutation ; Neoplasm Staging ; Phosphatidylinositol 3-Kinases ; genetics ; Quinazolines ; administration & dosage ; adverse effects ; Receptor, ErbB-2 ; metabolism ; Remission Induction

OBJECTIVETo compare the efficacy and safety of gefitinib or docetaxel in Chinese patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had failed previous platinum-based first-line chemotherapy.

METHODSWe retrospectively reviewed 222 Chinese NSCLC patients in the subgroup of INTEREST (gefitinib versus docetaxel in previously treated non-small cell lung cancer) study. Survival analysis was evaluated by Kaplan-Meier method, and Functional Assessment of Cancer Therapy-Lung (FACT-L) was used to compare the quality of life between gefitinib group and docetaxel group.

RESULTSA total of 222 patients were analyzed in this subgroup study. 107 patients were treated with gefitinib, and 115 patients treated with docetaxel. There were all balanced between the two groups in terms of sex, age, staging and pathology in patient characteristics. The median overall survival in the two groups was similar (11 months in the gefitinib group vs. 14.0 months in the docetaxel group, P = 0.783). The progression-free survival (PFS) was also similar between the two groups (median PFS: 3.4 months in gefitinib group vs. 3.8 months in docetaxel group, P = 0.214). The response rate in gefitinib group was significantly higher than that in the docetaxel group (21.9% vs. 9.1%, P = 0.016).

CONCLUSIONThe efficacy of gefitinib is similar with that of docetaxel in pretreated patients with locally advanced or metastatic NSCLC, however, gefitinib is more favorable in the tolerance and quality of life improvement.

Adult ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; pathology ; Diarrhea ; chemically induced ; Disease-Free Survival ; Exanthema ; chemically induced ; Female ; Humans ; Lung Neoplasms ; drug therapy ; pathology ; Male ; Neoplasm Staging ; Neutropenia ; chemically induced ; Platinum ; therapeutic use ; Quality of Life ; Quinazolines ; adverse effects ; therapeutic use ; Randomized Controlled Trials as Topic ; Remission Induction ; Retrospective Studies ; Survival Rate ; Taxoids ; adverse effects ; therapeutic use

OBJECTIVETo explore the efficacy and safety of erlotinib monotherapy for advanced non-small cell lung cancer (NSCLC).

METHODSTotally 50 patients with advanced NSCLC received oral erlotinib 150 mg/d treatment, and tumor specimen in 19 patients were collected for epidermal growth factor receptor (EGFR) gene mutation tests. Median survival (MS) was calculated using the Kaplan-Meier method.

RESULTSThe most common adverse events (AEs) were skin rash (96%) and diarrhea (32%). The overall survival (OS) of all patients was 21.8 months 95% confidential interval (CI): 17.1-26.4 months and the median progression-free survival (PFS) of all patients was 7.0 months (95% CI: 3.9-10.1 months). EGFR mutation analysis showed gene mutation in 8 cases and wild type in 11 cases. The objective response rate in patients with or without EGFR gene mutations were 62.5% and 9.1%, respectively (chi(2)=6.631, P=0.036). PFS in patients with or without EGFR gene mutations were 16.330 (95% CI: 2.803-29.857 months) and 5.570 months (95% CI: 2.441-8.699 months), respectively (chi(2)=8.799, P=0.003).

CONCLUSIONErlotinib monotherapy is safe and effective for some Chinese NSCLC patients after failure of prior chemotherapy.

Antineoplastic Agents ; adverse effects ; therapeutic use ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; Chi-Square Distribution ; Erlotinib Hydrochloride ; Female ; Humans ; Kaplan-Meier Estimate ; Lung Neoplasms ; drug therapy ; Male ; Middle Aged ; Multivariate Analysis ; Quinazolines ; adverse effects ; therapeutic use ; Regression Analysis ; Retrospective Studies ; Treatment Outcome

OBJECTIVETo observe the efficacy and the adverse effects of erlotinib in the treatment for advanced non-small cell lung cancer (NSCLC) in Chinese patients.

METHODSFrom November 2005 to March 2009, a total of 519 patients with unresectable, local advanced, relapsed or metastatic NSCLC were enrolled in the trial. All the patients were treated with erlotinib 150 mg/day until disease progression or intolerable toxicity or for other reasons. The response rate, time to disease progression, overall survival and toxicity were analyzed.

RESULTSOf these 519 patients, 1 case had complete response, 127 cases had partial response and 263 cases had stable disease, resulting in an overall response rate (CR + PR) of 26.7%, disease stable rate of 54.9% and disease control rate (CR + PR + SD) of 81.6%. The median time to progression was 6.44 months and median overall survival was 15.37 months. The major erlotinib treatment-related adverse events (AE) were mild (CTC AE 1/2), only 3 cases had severe adverse effect, 1 case had interstitial lung disease and died of respiratory failure.

CONCLUSIONThe study presents excellent response rates, time to progression and overall survival of erlotinib treatment for advanced NSCLC in Chinese patients, and its adverse events are tolerable.

Asian Continental Ancestry Group ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; pathology ; Diarrhea ; chemically induced ; Disease Progression ; Erlotinib Hydrochloride ; Exanthema ; chemically induced ; Female ; Follow-Up Studies ; Humans ; Lung Diseases, Interstitial ; chemically induced ; Lung Neoplasms ; drug therapy ; pathology ; Male ; Middle Aged ; Neoplasm Staging ; Protein Kinase Inhibitors ; adverse effects ; therapeutic use ; Quinazolines ; adverse effects ; therapeutic use ; Receptor, Epidermal Growth Factor ; adverse effects ; antagonists & inhibitors ; therapeutic use ; Remission Induction ; Survival Rate