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

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

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

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 evaluate the efficacy and safety of gefitinib for the treatment of advanced non-small cell lung cancer (NSCLC).

METHODS125 patients with advanced NSCLC who had failed or not tolerated or refused chemotherapy received 250 mg oral doses of gefitinib once daily until the disease progression or intolerable toxicity.

RESULTSA total of 125 NSCLC patients were studied, the overall response rate (RR) and the disease control rate (DCR) after administration of gefitinib were 35.2% (44/125) and 77.6% (97/125), respectively. The median progression-free survival and the median survival time were 5.8 and 11.2 months, respectively. The one-year survival rate was 40.5%. The response rate was significantly higher in females, adenocarcinoma and nonsmokers than that in males, non-adenocarcinoma and smokers (P < 0.05). The response rate did not show significant differences regarding ECOG score or previous treatment. The median progression-free survival was significantly longer in ECOG PS 0-1 and gefitinib effective patients than that in ECOG PS >or= 2 and gefitinib ineffective patients (P < 0.01). The median survival time was significantly longer in adenocarcinoma, nonsmokers and gefitinib effective patients than that in non-adenocarcinoma, smokers and gefitinib ineffective patients (P < 0.05). The most common side effects were rash (51.2%) and diarrhea (34.4%), but usually were mild.

CONCLUSIONGefitinib is effective and safe in the treatment of advanced NSCLC patients.

Adenocarcinoma ; drug therapy ; pathology ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; pathology ; Carcinoma, Squamous Cell ; drug therapy ; pathology ; Diarrhea ; chemically induced ; Disease-Free Survival ; Exanthema ; chemically induced ; Female ; Follow-Up Studies ; Humans ; Lung Neoplasms ; drug therapy ; pathology ; Male ; Middle Aged ; Neoplasm Staging ; Quinazolines ; adverse effects ; therapeutic use ; Survival Rate

OBJECTIVETo evaluate the efficacy,clinical benefits and toxicities of gemcitabine combined with erlotinib for advanced pancreatic cancer.

METHODClinical data of 20 patients with advanced pancreatic cancer treated with gemcitabine 1000 mg/m2 on day 1 and day 8 (repeated every 21 days) plus erlotinib 100-150 mg/d at Peking Union Medical College Hospital was reviewed retrospectively.

RESULTSNo patient achieved complete remission or partial remission, 11 patients (55%) had stable disease, and 9 patients (45%) experienced disease progression. The disease control rate was 55%, and clinical benefit rate was 30%. The median progression free survival was 4.0 months, and the median overall survival was 8 months. The total incidence of hematologic toxicity was 70%, including 15% of grade 3-4 leucopenia and 5% of grade 3-4 thrombocytopenia. Eleven patients (55%) had rash, which were all grade 1-2. One patient had grade 2 diarrhea and five had grade 1 transaminase elevation. No chemotherapy-related death occurred.

CONCLUSIONSGemcitabine combined with erlotinib is an effective regimen for pancreatic cancer with good clinical tolerance. The most common adverse events are hematologic toxicities and rash.

Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Deoxycytidine ; administration & dosage ; analogs & derivatives ; Erlotinib Hydrochloride ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Pancreatic Neoplasms ; drug therapy ; Quinazolines ; administration & dosage ; Retrospective Studies ; Treatment Outcome