Patients with small-cell lung cancer (SCLC) relapse within months after completing previous therapies. This study aimed to investigate the efficacy and safety of anlotinib as third- or further-line therapy in patients with short-term relapsed SCLC from ALTER1202. Patients with short-term relapsed SCLC (disease progression within 3 months after completing ⩾ two lines of chemotherapy) in the anlotinib (n = 67) and placebo (n = 34) groups were analyzed. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival, objective response rate (ORR), disease control rate, and safety. Anlotinib significantly improved median PFS/OS (4.0 vs. 0.7 months, P < 0.0001)/(7.3 vs. 4.4 months, P = 0.006) compared with placebo. The ORR was 4.5%/2.9% in the anlotinib/placebo group (P = 1.000). The DCR in the anlotinib group was higher than that in the placebo group (73.1% vs. 11.8%, P < 0.001). The most common adverse events (AEs) were hypertension (38.8%), loss of appetite (28.4%), and fatigue (22.4%) in the anlotinib group and gammaglutamyl transpeptidase elevation (20.6%) in the placebo group. No grade 5 AEs occurred. For patients with short-term relapsed SCLC, third- or further-line anlotinib treatment was associated with improved survival benefit. Further studies are warranted in this regard.
Humans ; Lung Neoplasms/drug therapy* ; Treatment Outcome ; Neoplasm Recurrence, Local/chemically induced* ; Quinolines/adverse effects*

Although various combinations of chemotherapy regimens have been tried for patients with esophageal cancer, their duration of survival is extremely poor. In this study, we investigated the safety and clinical efficacy of paclitaxel and cisplatin chemotherapy in metastatic or recurrent esophageal cancer. 32 patients enrolled in this study and the median age was 60 yr. Of all the 32, 28 patients (88%) had been treated previously, 22 of them with chemotherapy or radiation therapy. All patients in the study received biweekly paclitaxel (90 mg/m2) followed by cisplatin (50 mg/m2). One patient (3%) responded completely, and 12 patients (38%) showed a partial response; in 9 patients (28%) the disease remained stable, and in 10 patients (31%) it progressed. The objective response rate was 41%. The median duration of response was 4.8 months, and the median overall survival in all patients was 7 months. The 1-yr and 2-yr survival rates were 28.1% and 7.1%, respectively. Grade 3 or 4 of neutropenia and anemia were observed in 6 (19%) and 5 (16%) patients, respectively. The major non-hematologic toxicity was fatigue, but most of them could manageable. In conclusion, biweekly paclitaxel and cisplatin is effective in patients with metastatic or recurrent esophageal cancer.
Aged ; Anemia/chemically induced ; Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use ; Bone Neoplasms/drug therapy/secondary ; Cisplatin/administration & dosage/adverse effects ; Diarrhea/chemically induced ; Esophageal Neoplasms/*drug therapy/pathology ; Fatigue/chemically induced ; Humans ; Liver Neoplasms/drug therapy/secondary ; Lung Neoplasms/drug therapy/secondary ; Lymphatic Metastasis ; Male ; Middle Aged ; Nausea/chemically induced ; Neoplasm Recurrence, Local ; Paclitaxel/administration & dosage/adverse effects ; Survival Analysis ; Thrombocytopenia/chemically induced ; Time Factors ; Treatment Outcome ; Vomiting/chemically induced

OBJECTIVETo investigate the efficacy of the combination of gemcitabine with capecitabine in the chemotherapy for patients with relapsed or metastatic biliary tract carcinoma.

METHODSForty-one patients with unresectable relapsed or metastatic carcinoma of the biliary tract were treated from March 2000 to December 2004. The regimen consisted of intravenous administration of gemcitabine plus oral intake of capecitabine every 3 weeks for more than 2 cycles. The parameters including tumor response, clinical benefit rate,survival and safety were observed.

RESULTSThirty-six patients were valuable and 5 patients were excluded from this series due to various reasons. Eleven patients (30.1%) had a partial response and another 11 patients (30.1%) experieced stable disease with a clinical benefit rates of 61.1%. The median overall survival time and time to progression were 10 months and 6 months, respectively. The one-year survival rate was 40.0%. The adverse events including nausea, diarrhea and hand-foot syndrome, fatigue, neutropenia, thrombocytopenia were frequently observed, which were usually in grade I or II, rarely in grade III and none in grade IV (NCI-CTC).

CONCLUSIONOur results show that the regimen of gemcitabine combined with capecitabine is effective and well tolerated in patients with unresectable relapsed or metastatic carcinoma of the biliary tract.

Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Bile Duct Neoplasms ; drug therapy ; pathology ; Bile Ducts, Intrahepatic ; Capecitabine ; Cholangiocarcinoma ; drug therapy ; pathology ; Deoxycytidine ; administration & dosage ; analogs & derivatives ; Diarrhea ; chemically induced ; Female ; Fluorouracil ; administration & dosage ; analogs & derivatives ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Nausea ; chemically induced ; Neoplasm Metastasis ; Neoplasm Recurrence, Local ; Neutropenia ; chemically induced ; Remission Induction ; Survival Rate

OBJECTIVEThe aim of this study was to analyze the efficacy and toxicity of RNCE regimen in the treatment of relapsed or refractory B cell non-Hodgkin's lymphoma (NHL).

METHODSFrom January 2000 to December 2005, 46 patients with relapsed or refractory B cell NHL were treated by RNCE regimen with or without radiotherapy for the involved field. The clinical characteristics, response, toxicity and long-term survival results were analyzed retrospectively.

RESULTSA total of 46 patients were eligible. The complete response rate of second-line therapy was 52.17% (24/46), and the overall response rate was 82.61% (38/46). The median follow-up duration in this series was 69 months (range:6 to 102 months). The overall 1, 3, 5-year survival rate was 74.8%, 48.3%, 40.1%, respectively, with a median survival time of 30.2 months (5 to 65 months), and median progression free survival time of 10.9 months (2 to 31 months). The major toxicities were myelosuppression, GI toxicity, fatigue, fever and alopecia.

CONCLUSIONOur data show that RNCE regimen treatment is effective and well tolerated in patients with relapsed or refractory B cell non-Hodgkin's lymphoma.

Adolescent ; Adult ; Aged ; Alopecia ; chemically induced ; Antibodies, Monoclonal, Murine-Derived ; adverse effects ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Cisplatin ; administration & dosage ; Disease-Free Survival ; Drug Resistance, Neoplasm ; Etoposide ; administration & dosage ; Fatigue ; chemically induced ; Female ; Follow-Up Studies ; Humans ; Leukopenia ; chemically induced ; Lymphoma, B-Cell ; drug therapy ; pathology ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Remission Induction ; Retrospective Studies ; Rituximab ; Survival Rate ; Thrombocytopenia ; chemically induced ; Vinblastine ; administration & dosage ; analogs & derivatives ; Young Adult

Numerous studies have demonstrated the clinical activity of temozolomide, a second-generation alkylating agent, against malignant brain tumors, however, its activity has not been reported in an Asian population. This study analyzed the efficacy and toxicity of temozolomide in 25 adult patients with recurrent or progressive malignant gliomas after surgery and standard radiation therapy with or without chemotherapy, enrolled in our institution since July 2000. Sixteen patients had glioblastoma multiforme (GBM), six with anaplastic astrocytoma, and three with anaplastic oligodendroglioma. Of the 25 patients, 3 (12%) achieved a complete response (CR), 8 (32%) achieved a partial response (PR), 6 (24%) had stable disease (SD), and 8 (32%) had progressive disease (PD). Two patients achieved a CR, 4 patients achieved a PR, 3 patients had SD and 7 patients had PD in GBM, and 1 patient achieved a CR, 4 patients achieved a PR, 3 patients had SD, 1 patient had PD in the non-GBM patients. Median progression free survival was 8 weeks in GBM and 22 weeks in the non-GBM patients. The median overall survival of each group was 17 weeks and 28 weeks. Temozolomide demonstrated moderate activity in recurrent and progressive malignant gliomas without serious toxicity.
Vomiting/chemically induced ; Treatment Outcome ; Survival Analysis ; Neoplasm Recurrence, Local ; Nausea/chemically induced ; Middle Aged ; Male ; Magnetic Resonance Imaging ; Liver Diseases/chemically induced ; Leukopenia/chemically induced ; Humans ; Glioma/*drug therapy/radiotherapy/surgery ; Female ; Drug Administration Schedule ; Dacarbazine/administration & dosage/adverse effects/*analogs & derivatives/therapeutic use ; Combined Modality Therapy ; Brain Neoplasms/*drug therapy/radiotherapy/surgery ; Brain/drug effects/pathology ; Antineoplastic Agents, Alkylating/administration & dosage/adverse effects/therapeutic use ; Adult ; Adolescent ; Administration, Oral

OBJECTIVEThe aim of this study is to evaluate the efficacy and safety of Gefitinib in the treatment of Chinese patients with recurrent advanced non-small-cell lung cancer (NSCLC).

METHODS120 patients were enrolled in this trial from September 2002 to March 2005, and 103 patients were evaluable. All patients were histologically or/and cytologically confirmed to have a locally advanced or metastatic NSCLC, and failed to previous standard treatments. The patients received orally 250 mg of Gefitinib once daily until the disease progression or intolerance to toxicity. First evaluation of response was undertaken one month after drug initiation, then every 2 or 3 months till disease progression. Each patient was followed up every 6 months untill death or end of follow-up.

RESULTSAmong the 103 evaluable patients, the objective response rate was 18.4% (19/103), and the disease control rate was 51.5% (53/103). The median time to progression (mTTP) was 3 months (range: 0.2 approximately 40), the median survival time (MST) was 9.8 months (range: 0.5 approximately 51), the 1-, 2-, 3-year survival rates were 44.7%, 26.4% and 13.2%, respectively. The TTP of 41 patients was longer than 6 months with a MST of 25.5 months. The results of COX model analysis suggested that the patients with adenocarcinoma, rash and favourable performance status (PS) had longer TTP. The patients with favourable PS and well controlled disease had longer survival time. Adverse events included skin rash, dry skin, diarrhea and elevation of serum glutamate pyruvate transaminase (SGPT), and were usually mild.

CONCLUSIONGefitinib is effective in treatment of patient with recurrent advanced NSCLC. The patients with controlled disease may achieve a long survival, and the adverse reactions are mild and tolerable.

Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Bone Neoplasms ; drug therapy ; secondary ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; pathology ; secondary ; Diarrhea ; chemically induced ; Exanthema ; chemically induced ; Female ; Follow-Up Studies ; Humans ; Lung Neoplasms ; drug therapy ; pathology ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Proportional Hazards Models ; Quinazolines ; adverse effects ; therapeutic use ; Remission Induction ; Survival Rate ; Young Adult

OBJECTIVEThis clinical study was designed to evaluate the efficacy and toxicity of the combined regimen of docetaxel, 5-Fu and DDP (TPF) in the treatment of advanced or relapsed nasopharyngeal carcinoma (NPC).

METHODSFifty-six patients with newly diagnosed or recurrent/metastatic NPC following chemotherapy or radiotherapy were enrolled. Both docetaxel and DDP were administered intravenously for 6 hours at the dose of 70 mg/m2 on D1. 5-Fu was given at a dose of 400-500 mg/m2 for 6 hours from D1 to D5. Dexamethasone was routinely administered before injection of docetaxel. This combination was repeated every 3 to 4 weeks, and continued for 4-6 cycles or until PD for the responders.

RESULTSFifty-one (91.1%) patients were evaluable for response assessment. The response rate for whole group was 72.5% (37/51) with a CR rate of 9.8% (5/51). The stable disease accounted for 17.6% (9/51). There were 17(30.4%) chemotherapy-naïve patients. The overall response rate in those was 82.4% with a CR rate of 29.4%. However, the response rate for previously treated patients was 64.7% without CR. Twelve patients had progressed disease, including 5 (8.9%) died of disease progression with a median follow-up of 11 month (ranged from 1 to 19 months). Totally, 196 courses of chemotherapy were administered. The major toxicity was myelosupression, nausea/vomiting. The incidence of leucopenia was 48% with 22.2% of these in NCI grade II or IV. But only 2 patients (3.6%) experienced leucopenia with a fever. Other mild toxicities including alopecia, asthenia, mucositis and diarrhea were also observed.

CONCLUSIONOur preliminary outcome shows docetaxel, 5-Fu and DDP combination is effective and safe for the patients with advanced or relapsed nasopharyngeal carcinoma. But further clinical study is warranted.

Adolescent ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Carcinoma, Squamous Cell ; drug therapy ; pathology ; Cisplatin ; administration & dosage ; Female ; Fluorouracil ; administration & dosage ; Follow-Up Studies ; Humans ; Leukopenia ; chemically induced ; Male ; Middle Aged ; Nasopharyngeal Neoplasms ; drug therapy ; pathology ; Nausea ; chemically induced ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Remission Induction ; Taxoids ; administration & dosage ; Young Adult

OBJECTIVETo evaluate the efficacy and safety of gefitinib as maintenance therapy for patient with advanced non-small lung cancer (NSCLC).

METHODSFrom Oct. 2002 to Apr. 2006, 173 patients with advanced NSCLC received oral gefitinib 250 mg per day after completion of induction chemotherapy (62 patients, maintenance therapy group) or recurrence after one or more regimens of chemotherapy (111 patients, recurrent group). Median survival (MS) and progress free survival (PFS) were calculated using the Kaplan-Meier method, and Cox regression analysis was used to analyze the difference between the sub-groups stratified by smoking, pathological type, liver metastasis and gefitinib treatment result.

RESULTSMS of maintenance therapy group and recurrent group were 25.0 months (95% CI: 19.3-30.7) and 12.5 months (95% CI: 9.3-15.7), respectively. There was a statistically significant difference between the above two groups (P = 0.0004). PFS of maintenance therapy group and recurrent group was 16.5 months (95% CI: 8.7-24.3) and 9.2 months (95% CI: 7.5-10.9), respectively. There was also a statistically significant difference between these two groups (P = 0. 0000). It was found that median MS in maintenance therapy group was significantly correlated with smoking status, pathology type, liver metastasis and objective response of gefitinib.

CONCLUSIONMaintenance therapy with gefitinib after induction chemotherapy may improve overall survival in patient with non-small cell lung cancer.

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 ; Liver Neoplasms ; secondary ; Lung Neoplasms ; drug therapy ; pathology ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Proportional Hazards Models ; Quinazolines ; adverse effects ; therapeutic use ; Remission Induction ; Smoking ; Survival Rate

In order to evaluate the effects of FLAG regimen in treatment of refractory and relapsed acute myeloid leukemia (AML), 27 patients with refractory or relapsed acute myeloid leukemia (10 refractory AML patients, 17 relapsed AML patients) were treated with FLAG regimen. The results show that the rate of complete remission was 48.2% (13/27), the rate of partial remission was 14.8% (4/27), and the overall response rate was 63.0%. Main toxicities were gastrointestinal side effectes, myelosupression and neutropenia. It is concluded that FLAG regimen can be employed in treatment of the refractory or relapsed patients who were not respond to other regimen, and the regiment was safe.
Adolescent ; Adult ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Cytarabine ; administration & dosage ; adverse effects ; Diarrhea ; chemically induced ; Drug Resistance, Neoplasm ; Female ; Granulocyte Colony-Stimulating Factor ; administration & dosage ; adverse effects ; Humans ; Leukemia, Monocytic, Acute ; drug therapy ; pathology ; Leukemia, Myeloid, Acute ; drug therapy ; pathology ; Leukemia, Myelomonocytic, Acute ; drug therapy ; pathology ; Male ; Middle Aged ; Nausea ; chemically induced ; Neoplasm Recurrence, Local ; Respiratory Tract Infections ; chemically induced ; Treatment Outcome ; Vidarabine ; administration & dosage ; adverse effects ; analogs & derivatives

UNLABELLEDOBJECTIVE To assess the efficacy of concurrent chemoradiation with paclitaxel and platinum and external irradiation, and to compare the effect of extensive regional field irradiation with conventional local field irradiation for locally advanced esophageal cancer.

METHODSFrom Oct. 2000 to Jan. 2006, 89 patients with locally advanced esophageal cancer were registered in this study. All patients were inoperable or refused to undergo operation. Patients were divided into two groups: extensive regional field group (51 patients) and conventional field group (38 patients). Patients received radiotherapy at a total dose of 60 Gy in 30 fractions within 7 weeks,and concurrent paclitaxel 125 mg/m2 on D1, cisplatin 20 mg/m2 on D1-D3, or oxaliplatin 130 mg/m2 on D2 in the fist and fourth week of external radiation.

RESULTSOf these patients, 87.6% completed the treatment regimen with a response rate of 75.5% and 66.7% in the extensive regional field group and conventional field group, respectively. Grade 3 or severe toxicities of leucopenia (33.3% vs. 23.7%), thrombocytopenia (76.0% vs. 2.6%), and esophagitis (17.7% vs. 26.3%) were observed in extensive regional field group and conventional field group, respectively. Major late toxic effect was lung fibrosis. There were no statistically significant differences in the incidence of the toxicity profile between two groups. The overall 3-year survival rates was 32.8%, and the overall 3-year recurrence and metastasis-free survival rates was 34.5%. The overall 3-year locoregional control rate was 44.0%. No significant difference was found between two groups in the 3-year survival (38.2% % vs. 28.1%, P = 0.59). For the patients with stage II and stage III cancers who completed the planned treatment, large regional field radiotherapy significantly improved the 3-year survival (57.3% vs. 22.2% , P = 0.03) or 3-year recurrent and metastasis-free survival (55.5% vs. 23.0%, P = 0.03) or 3-year locoregional control (65.9% vs. 30.2%, P = 0.02) than conventional field radiotherapy.

CONCLUSIONhistorical results, the combination of paclitaxel/platinum and radiation in this study can improve the survival for locally advanced esophageal, and the side effect is well tolerated. Compared with the conventional field group, concurrent chemoradiotherapy with the large regional field can significantly improve 3-year survival and locoregional control for stage II or stage III esophageal cancer.

Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Carcinoma, Squamous Cell ; drug therapy ; pathology ; radiotherapy ; Cisplatin ; administration & dosage ; Combined Modality Therapy ; Esophageal Neoplasms ; drug therapy ; pathology ; radiotherapy ; Esophagitis ; chemically induced ; etiology ; Female ; Follow-Up Studies ; Humans ; Leukopenia ; chemically induced ; etiology ; Lymphatic Metastasis ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Organoplatinum Compounds ; administration & dosage ; Paclitaxel ; administration & dosage ; Particle Accelerators ; Radiotherapy Dosage ; Radiotherapy, High-Energy ; adverse effects ; methods ; Remission Induction ; Survival Rate ; Thrombocytopenia ; chemically induced ; etiology