1.Anlotinib as third- or further-line therapy for short-term relapsed small-cell lung cancer: subgroup analysis of a randomized phase 2 study (ALTER1202).
Jianhua SHI ; Ying CHENG ; Qiming WANG ; Kai LI ; Lin WU ; Baohui HAN ; Gongyan CHEN ; Jianxing HE ; Jie WANG ; Haifeng QIN ; Xiaoling LI
Frontiers of Medicine 2022;16(5):766-772
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
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Lung Neoplasms/drug therapy*
;
Treatment Outcome
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Neoplasm Recurrence, Local/chemically induced*
;
Quinolines/adverse effects*
2.Bevacizumab toxicity in heavily pretreated recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers.
Jovana Y MARTIN ; Renata R URBAN ; John B LIAO ; Barbara A GOFF
Journal of Gynecologic Oncology 2016;27(5):e47-
OBJECTIVE: Bevacizumab was recently approved by the US Food and Drug Administration for use in recurrent platinum resistant epithelial ovarian cancer (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) when no more than two prior cytotoxic regimens have been used; due to concerns for gastrointestinal perforation. We sought to determine bevacizumab-related toxicities in heavily pretreated recurrent EOC. METHODS: We performed a retrospective chart review of patients with recurrent EOC, FTC, and PPC from 2001 to 2011. Patients who received at least two prior chemotherapy regimens before bevacizumab were included. Medical records were reviewed for bevacizumab associated toxicities. The Wilcoxon-Mann-Whitney test was used to compare quantitative variables. Survival was estimated with the Kaplan-Meier method. RESULTS: Sixty patients met inclusion criteria. At the start of bevacizumab treatment, the median age was 60 years and the median body mass index was 26.5 kg/m². More than 50% of patients received bevacizumab after three prior cytotoxic regimens. Grade 3 or higher bevacizumab associated toxicity events occurred in four patients, including one patient who developed a rectovaginal fistula. The median overall survival from the start of bevacizumab treatment was 21.05 months (95% CI, 18.23 to 32.67; range, 1.9 to 110 months). The number of cytotoxic regimens prior to bevacizumab treatment did not differ in those that experienced a toxicity versus those that did not (p=0.66). CONCLUSION: The use of bevacizumab in heavily pretreated EOC, FTC, or PPC is worth consideration.
Adult
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Aged
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Aged, 80 and over
;
Angiogenesis Inhibitors/*therapeutic use
;
Bevacizumab/*adverse effects
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Fallopian Tube Neoplasms/*drug therapy
;
Female
;
Humans
;
Intestinal Perforation/chemically induced
;
Middle Aged
;
Neoplasm Recurrence, Local/*drug therapy
;
Neoplasms, Glandular and Epithelial/*drug therapy
;
Ovarian Neoplasms/*drug therapy
;
Peritoneal Neoplasms/*drug therapy
;
Retrospective Studies
3.Evaluation of induction chemotherapy with vinorelbine plus cisplatin (NP) or docetaxel plus cisplatin (TP) combined with concurrent chemoradiotherapy for patients with locally advanced nasopharyngeal carcinoma.
Shu-hong HAN ; Lan YU ; Zhen ZHANG ; Pei-juan ZHANG ; Hai-ping SONG ; Cheng-ye GUO
Chinese Journal of Oncology 2013;35(8):623-626
OBJECTIVETo compare the efficacy and side effects of induction chemotherapy with vinorelbine plus cisplatin (NP) or docetaxel plus cisplatin (TP) combined with concurrent chemoradiotherapy in treating locally advanced nasopharyngeal carcinoma (NPC).
METHODSFrom January 2005 to December 2009, 146 patients with locally advanced nasopharyngeal carcinoma treated in our department were randomized into NP group (76 patients) or TP group (70 patients). Both groups received two cycles of induction chemotherapy and concurrent chemoradiotherapy. After three weeks of induction chemotherapy, the patients received concurrent chemoradiotherapy. The chemotherapy was recycled every three weeks. Two groups were treated with intensity-modulated radiation therapy.
RESULTSThe short-term efficacy of NP group was similar to that of TP group. The 3-year overall survival rates, disease-free-survival rates, locoregional relapse-free survival rates and distant metastasis-free survival rates in the NP and TP groups were 84.2% and 82.9%, 71.1% and 74.3%, 89.5% and 91.4%, 81.6% and 77.1%, respectively (P > 0.05). The occurrence rates of leucopenia, anemia and acute mucositis were significantly higher in the TP group than those in the NP group (P < 0.05). The gastrointestinal toxicity, dermatitis and liver toxicity were similar in the two groups.
CONCLUSIONSThe efficacy of NP regimen induction chemotherapy plus concurrent chemordiotherapy for advanced NPC is similar to that of TP regimen. The toxicity of the NP regimen is lower than that of NP regimen, tolerable, and with a good compliance.
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Bone Neoplasms ; secondary ; Carcinoma ; Chemoradiotherapy ; Cisplatin ; administration & dosage ; adverse effects ; Disease-Free Survival ; Female ; Follow-Up Studies ; Humans ; Induction Chemotherapy ; Leukopenia ; chemically induced ; etiology ; Liver Neoplasms ; secondary ; Lung Neoplasms ; secondary ; Male ; Middle Aged ; Mucositis ; chemically induced ; etiology ; Nasopharyngeal Neoplasms ; pathology ; therapy ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Radiotherapy, Intensity-Modulated ; Remission Induction ; Survival Rate ; Taxoids ; administration & dosage ; adverse effects ; Vinblastine ; administration & dosage ; adverse effects ; analogs & derivatives ; Young Adult
4.Intraarterial chemotherapy with gemcitabine and cisplatin in locally advanced or recurrent penile squamous cell carcinoma.
Jian-Ye LIU ; Yong-Hong LI ; Zhuo-Wei LIU ; Zhi-Ling ZHANG ; Yun-Lin YE ; Kai YAO ; Hui HAN ; Zi-Ke QIN ; Fang-Jian ZHOU
Chinese Journal of Cancer 2013;32(11):619-623
The prognosis of locally advanced or recurrent squamous cell carcinoma (SCC) of the penis after conventional treatment is dismal. This study aimed to evaluate the therapeutic effects of intraarterial chemotherapy with gemcitabine and cisplatin on locally advanced or recurrent SCC of the penis. Between April 1999 and May 2011, we treated 5 patients with locally advanced penile SCC and 7 patients with recurrent disease with intraarterial chemotherapy. The response rate and toxicity data were analyzed, and survival rates were calculated. After 2 to 6 cycles of intraarterial chemotherapy with gemcitabine and cisplatin, 1 patients with locoregionally advanced disease achieved a complete response, and 4 achieved partial response. Of the 7 patients with recurrent disease, 2 achieved complete response, 3 achieved partial response, 3 had stable disease, and 1 developed progressive disease. An objective tumor response was therefore achieved in 10 of the 12 patients. The median overall survival for the patients was 24 months (range, 10-50 months). Three out of 10 patients who responded were long-term survivors after intraarterial chemotherapy. Intraarterial chemotherapy with gemcitabine and cisplatin may be effective and potentially curative in locoregionally advanced or recurrent penile SCC. The contribution of this therapy in the primary management of advanced or recurrent penile SCC should be prospectively investigated.
Adult
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Aged
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Antineoplastic Combined Chemotherapy Protocols
;
administration & dosage
;
adverse effects
;
therapeutic use
;
Carcinoma, Squamous Cell
;
drug therapy
;
pathology
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Cisplatin
;
administration & dosage
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Deoxycytidine
;
administration & dosage
;
analogs & derivatives
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Disease Progression
;
Follow-Up Studies
;
Humans
;
Infusions, Intra-Arterial
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Leukopenia
;
chemically induced
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Male
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Middle Aged
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Neoplasm Recurrence, Local
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Neoplasm Staging
;
Penile Neoplasms
;
drug therapy
;
pathology
;
Survival Rate
5.Phase II clinical trial of neoadjuvant therapy with carboplatin plus paclitaxel for locally advanced triple-negative breast cancer.
Wen-yue MA ; Pin ZHANG ; Bai-lin ZHANG ; Xiang WANG ; Xiao-zhou XU ; Shan ZHENG ; Jia-yu WANG ; Rui-gang CAI ; Peng YUAN ; Fei MA ; Ying FAN ; Bing-he XU
Chinese Journal of Oncology 2012;34(10):770-774
OBJECTIVETo evaluate the efficacy, safety and survival of combination of carboplatin plus paclitaxel as neoadjuvant chemotherapy (NACT) for patients with locally advanced triple-negative breast cancer (TNBC), and explore an optimal regimen for TNBC.
METHODSPatients with core needle biopsy confirmed pathological diagnosis of IIA ∼ IIIC invasive breast cancer, negative for estrogen and progesterone receptors and HER2 by immunohistochemistry, and with indication for NACT were eligible in this study. The biopsy tumor tissues were tested for CK5/6, CK14, EGFR and Ki67. The patients received paclitaxel 175 mg/m(2) on day 1, carboplatin at an area under the curve 5 mg×min/ml on day 2 of every 21 days. The clinical response was evaluated every 2 cycles according to Standard RECIST 1.0 criteria and surgery was done after four to six cycles. Pathological complete remission (pCR) was defined if absence of invasive tumor in the breast and axillary lymph nodes samples or residual carcinoma in situ only.
RESULTSOverall, thirty-one patients were enrolled from January 2008 to November 2010. The median age was 51 years and 83.9% of the patients were diagnosed as stage IIB to IIIC diseases. 30 Patients completed chemotherapy as planed while one patient changed regimen due to paclitaxel allergy. Twenty-eight patients could be evaluated for clinical efficacy, of which CR, PR, SD, PD were achieved in 4, 20, 3 and 1 women, respectively. The objective response rate was 85.7%. The expression rate of CK5/6, CK14 and EGFR were 88.9% (24/27), 59.3% (16/27) and 63% (17/27), respectively. Among 27 patients who received modified radical mastectomy or breast-conserving surgery, 11 patients obtained pCR, with a pCR rate of 40.7% (95%CI 22.2% - 59.3%). Five of six CK5/6- and CK14-positive patients achieved pCR. All the 31 patients could be evaluated for toxicity according to the NCI-CTC v3.0 criteria. The major toxicities were neutropenia (93.5%), vomiting (45.2%) and ALT/AST increase (32.3%), and grade 3-4 toxicities accounted for 74.2%, 3.2%, 0, respectively. Until December 2011, at a median follow-up of 28.9 months (range 5 - 47.9), eight patients developed recurrence including 5 patients died. Among 11 patients with pCR, one suffered from lung metastasis at 45 months after diagnosis and survived with tumor until now. The other ten were alive and disease free. The 3-year DFS and OS were 62% and 74.7%, respectively.
CONCLUSIONSAs a neoadjuvant treatment for triple-negative breast cancer, carboplatin plus paclitaxel regimen achieves notable higher objective response rate and pCR rate compared with the anthracycline plus paclitaxel regimen reported in the literature, and is well tolerable. It is an optimized regimen for TNBC.
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Biopsy, Large-Core Needle ; Breast Neoplasms ; drug therapy ; metabolism ; pathology ; Carboplatin ; administration & dosage ; Carcinoma, Ductal, Breast ; drug therapy ; metabolism ; pathology ; Chemotherapy, Adjuvant ; Disease-Free Survival ; Female ; Follow-Up Studies ; Humans ; Lung Neoplasms ; secondary ; Middle Aged ; Neoadjuvant Therapy ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Neutropenia ; chemically induced ; Paclitaxel ; administration & dosage ; Receptor, ErbB-2 ; metabolism ; Receptors, Estrogen ; metabolism ; Receptors, Progesterone ; metabolism ; Remission Induction ; Survival Rate ; Young Adult
6.Efficacy and survival status of retuximab-NCE regimen treatment in patients with relapsed or refractory B cell non-Hodgkin's lymphoma.
Yun HOU ; Hua-qing WANG ; Kai FU ; Xian-ming LIU ; Hui-lai ZHANG ; Zheng-zi QIAN ; Li-hua QIU ; Wei LI ; Shi-yong ZHOU ; Lan-fang LI ; Xi-shan HAO
Chinese Journal of Oncology 2012;34(4):306-310
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
7.Comparison of the efficacy of CCCG-97 and BFM-90 protocols in the treatment for children with mature B-cell non-Hodgkin's lymphoma.
Jian-hua MENG ; Yi-jin GAO ; Feng-juan LU ; Xiao-wen ZHAI ; Hong-sheng WANG ; Jun LI
Chinese Journal of Oncology 2012;34(3):222-227
OBJECTIVEThe aim of this study was to evaluate the efficacy and toxicity of the CCCG-97 and BFM-90 protocols in the treatment of pediatric patients with B-cell non-Hodgkin's lymphoma (B-NHL) retrospectively, and to explore the optimal therapeutic strategy.
METHODSForty-five consecutive untreated patients (age of 18 years or less) with newly diagnosed B-NHL (including Burkitt Lymphoma and diffuse large B-cell lymphoma), treated in our hospital between July 1999 and December 2008 were enrolled in this study. The patients were classified into 2 groups by different protocols. From July 1999 to December 2004, twenty-one 3- to 13.8-year-old children were enrolled in the CCCG-97 group, with 1 in stage I/II, and 20 in stage III/IV(St Jude staging). From January 2005 to December 2008, twenty-four 2.8- to 14.1-year-old cases were enrolled in the BFM-90 group, with 3 in stage I/II, and 21 in stage III/IV (St Jude staging). The survival rates were evaluated by Kaplan-Meier analysis.
RESULTSForty of the 45 patients (88.9%) reached complete response (CR) after 2 courses of chemotherapy. In the CCCG-97 group, the CR rate was 95.2% (20/21 pts), while that in the BFM-90 group was 83.3% (20/24 pts). At a median follow-up time of 62 (17 to 131) months, the 5-year event-free survival (EFS) was 71.8% for all patients, and 69.1% for Stage III/IV, respectively. In the CCCG-97 group, the 3-year EFS was 76.2%. In the BFM-90 group, it was 75.0%. There was no significant difference in survival rates between the CCCG-97 and BFM-90 groups (P=0.975). Unfavorable events recorded were as follows: Death of progression before achieving CR during induction therapy in 4 cases, and relapse after achieving CR in 6 cases. The relapse rates were 19.0% (4/21 pts) in the CCCG-97 group and 8.3% (2/24 pts) in the BFM-90 group, with a non-significant statistical difference (P=0.292). Major toxicities were myelosuppression and mucositis, especially in the BFM-90 group, but were tolerable and manageable. five patients in the BFM-90 group received rituximab, 2 patients (Stage III) achieved CR, while the other 3 patients (Stage IV) had progressive disease or relapse.
CONCLUSIONSShort-pulse and intensive chemotherapy, stratified according to stage of disease, can improve the survival rate of pediatric mature B-NHL. The efficacy of the CCCG-97 protocol and BFM-90 protocol is comparable and the toxicity is tolerable.
Adolescent ; Antibodies, Monoclonal, Murine-Derived ; therapeutic use ; Antineoplastic Agents ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Burkitt Lymphoma ; drug therapy ; pathology ; Child ; Child, Preschool ; Disease-Free Survival ; Female ; Follow-Up Studies ; Humans ; Lymphoma, Large B-Cell, Diffuse ; drug therapy ; pathology ; Male ; Mucositis ; chemically induced ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Remission Induction ; Retrospective Studies ; Rituximab ; Survival Rate
8.Effecacy of three-dimensional conformal radiation therapy combined with Tegafur for postoperative recurrent rectal carcinoma.
Chinese Journal of Oncology 2011;33(4):299-301
OBJECTIVETo observe the local control rate, survival time and side effect of three-dimensional conformal radiation therapy combined with Tegafur for postoperative recurrent rectal carcinoma.
METHODSForty patients with postoperative recurrent rectal carcinoma received three-dimensional conformal radiation therapy, 1.8 - 2.0 Gy/once, 5 times every week and the total dose was 54 - 65 Gy. At the same time, the patients took Tegafur orally 40 mg/m(2) twice per day for consecutive 28 days, and one cycle lasted for 42 days. The chemotherapy was applied for 2 cycles after radiotherapy.
RESULTSThe total effective rate (CR + PR) was 70.0%, improvement rate was 90.0%, 1-year survival rate was 70.0%, and 1-year local control rate was 62.5%. There was only a little side effect.
CONCLUSIONSThree-dimensional conformal radiation therapy combined with Tegafur for postoperative recurrent rectal carcinoma have definite effect, with a high local control rate, and patients well tolerance the treatment without serious side effect. It can apparently improve the life quality of the patients.
Adenocarcinoma ; drug therapy ; radiotherapy ; surgery ; Adult ; Aged ; Antimetabolites, Antineoplastic ; adverse effects ; therapeutic use ; Combined Modality Therapy ; Diarrhea ; etiology ; Exanthema ; chemically induced ; etiology ; Female ; Humans ; Leukopenia ; etiology ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Postoperative Period ; Quality of Life ; Radiotherapy, Conformal ; adverse effects ; Rectal Neoplasms ; drug therapy ; radiotherapy ; surgery ; Remission Induction ; Survival Rate ; Tegafur ; adverse effects ; therapeutic use
9.Efficacy of cetuximab combined with chemotherapy for patients with advanced colorectal cancer and unclear K-ras status.
Gui-fang GUO ; Liang-ping XIA ; Hui-juan QIU ; Rui-hua XU ; Bei ZHANG ; Wen-qi JIANG ; Fei-fei ZHOU ; Fang WANG
Chinese Journal of Oncology 2010;32(10):777-781
OBJECTIVETo study the efficacy and safety of cetuximab combined with chemotherapy for patients with advanced colorectal cancer (ACRC) and unclear K-ras status.
METHODSClinical data of 102 ACRC patients, treated by cetuximab combined with chemotherapy in Sun Yat-sen Cancer Center from March 2005 to December 2008, were collected. The cumulative survival rate, objective response rate (ORR), disease control rate (DCR), progression free survival (PFS) of the cases were calculated. The difference in ORR, DCR, PFS and oval survival (OS) between the regimens used as first-line and non-first-line treatment, and between the regimens including oxaliplatin and irinotecan were compared.
RESULTSThe overall ORR of cetuximab plus chemotherapy was 43.1%, DCR 73.5%, median PFS 4.0 months, OS 28.5 months, and the 1-year, 3-year, and 5-year survival rate was 89.2%, 50.9% and 27.5%, respectively. The differences in ORR (50.0% vs. 40.0%, P = 0.344), DCR (78.1% vs. 72.9%, P = 0.571) and OS (51.0 months vs. 35.0 months, P = 0.396) between the regimens as first line and as non-first line treatment were not statistically significant. However, the PFS of the regimen as first-line was longer than that as non-first-line treatment (PFS 5.5 months vs. 3.0 months, P = 0.001). The differences in ORR (54.2% vs. 40.0%, P = 0.223), DCR (79.2% vs. 74.7%, P = 0.654), PFS (5.0 months vs. 3.0 months, P = 0.726) and OS (36.0 months vs. 40.0 months, P = 0.759) between cetuximab plus oxliplatin and irinotecan were not statistically significant. The most common side effects of cetuximab plus chemotherapy were acneiform eruption (80.4%, grade 3-4 in 9.8%), neutropenia (66.7%, grade 3-4 in 18.6%), and diarrhea (19.6%, grade 3-4 in 5.9%). No treatment-related death was recorded.
CONCLUSIONPatients with advanced colorectal cancer and unclear K-ras treated by cetuximab combined with chemotherapy have good ORR and OS, and the regimen is safe with less adverse events for them. There is no significant difference between the efficacies of regimens as first line and as non-first line treatment, and between cetuximab plus oxliplatin and cetuximab plus irinotecan regimens.
Acneiform Eruptions ; chemically induced ; Adenocarcinoma ; drug therapy ; metabolism ; pathology ; secondary ; surgery ; Adult ; Antibodies, Monoclonal ; adverse effects ; therapeutic use ; Antibodies, Monoclonal, Humanized ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Camptothecin ; administration & dosage ; analogs & derivatives ; Cetuximab ; Colonic Neoplasms ; drug therapy ; metabolism ; pathology ; surgery ; Diarrhea ; chemically induced ; Disease-Free Survival ; Female ; Follow-Up Studies ; Humans ; Liver Neoplasms ; drug therapy ; secondary ; Lung Neoplasms ; drug therapy ; secondary ; Lymphatic Metastasis ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Neutropenia ; chemically induced ; Organoplatinum Compounds ; administration & dosage ; Rectal Neoplasms ; drug therapy ; metabolism ; pathology ; surgery ; Remission Induction ; Survival Rate ; ras Proteins ; metabolism
10.Analysis of the efficacy and safety of gefitinib in the treatment of recurrent advanced non-small cell lung cancer in an expanded access program (EAP).
He HUANG ; Yang ZHANG ; Hong-yun ZHAO ; Zhi-qiang WANG ; Fei XU ; Guang-chuan XU ; Li ZHANG ; Zhong-zhen GUAN
Chinese Journal of Oncology 2009;31(2):148-151
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

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