1.Efficacy and Safety of Apatinib in Treating Advanced Colorectal Cancer.
Ning Ning LI ; Jian Feng ZHOU ; Lin ZHAO ; Hong Yan YING ; Ning JIA
Acta Academiae Medicinae Sinicae 2019;41(2):170-174
Objective To assess the efficacy and safety of apatinib in the treatment of advanced colorectal cancer(CRC). Methods The clinical data of 16 CRC patients treated with apatinib after failure of prior lines of treatment were retrospectively analyzed in terms of objective response rate,disease control rate,progression-free survival,overall survival,adverse events,and prognostic factors. Results The efficacy was evaluable in 14 patients,among whom the objective response rate was 7.1% and the disease control rate was 50%.The median progression-free survival was 3 months(95%CI=1.57-4.42),and the median overall survival was 6.5 months(95%CI=4.10-8.89).The safety was evaluable in 16 patients,among whom the most common grade 3 adverse events were hypertensinon(37.5%)and proteinuria(25%).No grade 4 adverse event was observed.Multivariate analysis did not show any factor directly related to survival.Conclusion Apatinib may be effective in treating advanced CRC,with tolerable side effects.
Antineoplastic Agents
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adverse effects
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therapeutic use
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Colorectal Neoplasms
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drug therapy
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Humans
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Pyridines
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adverse effects
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therapeutic use
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Retrospective Studies
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Survival Analysis
2.Etoricoxib versus indometacin in the treatment of Chinese patients with acute gouty arthritis: a randomized double-blind trial.
Ting LI ; Shun-le CHEN ; Qing DAI ; Xing-Hai HAN ; Zhan-Guo LI ; Dong-Hai WU ; Xiao ZHANG ; Jie-Ruo GU ; Nan-Ping YANG ; Ling-Yun SUN ; Miu-Jia ZHANG ; Xing-Fu LI ; Chun-de BAO
Chinese Medical Journal 2013;126(10):1867-1871
BACKGROUNDAcute gout is an intensely painful, inflammatory arthritis. Although the non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for this condition, the efficacy is based on only a few studies, particularly in China. We tried to assess the safety and efficacy of etoricoxib in the treatment of acute gouty arthritis in China.
METHODSA randomized, double-blind, active comparator study was conducted at 10 sites in China. Patients (n = 178; ≥ 18 years of age) with acute gouty attack (< 48 hours) were treated for 5 days with etoricoxib (120 mg/d; n = 89) or indometacin (75 mg twice daily; n = 89). The primary efficacy end point was self-assessed pain in the affected joint (0-4 point Likert scale) from days 2 - 5. Secondary end points included investigator assessments of tenderness and swelling, patient/ investigator global assessments of response to therapy, and patients discontinuing treatment. Safety was assessed by adverse events (AEs).
RESULTSEtoricoxib and indometacin had comparable primary and secondary end points. Mean change difference from baseline from days 2 - 5 was 0.03 (95% confidence interval (CI) -0.19 to 0.25; P = 0.6364), which fell within the prespecified comparative bounds of -0.5 to 0.5. No severe AEs were associated with etoricoxib use. Non-severe AEs were mainly digestive and general, and most (73.7%) were mild, although they caused withdrawal of two subjects in the etoricoxib group, due to bilateral renal calculi and uronephrosis of the left kidney (unrelated to etoricoxib) and fever and chills (potentially etoricoxib-related). Overall, AEs were similar, although the absolute number of AEs in the etoricoxib group (n = 31) was less than the indometacin group (n = 34).
CONCLUSIONSEtoricoxib (120 mg once daily) is effective in treating acute gout, is generally safe and well-tolerated, and is comparable in efficacy to indometacin (75 mg twice daily).
Adult ; Aged ; Arthritis, Gouty ; drug therapy ; Cyclooxygenase Inhibitors ; adverse effects ; therapeutic use ; Double-Blind Method ; Female ; Humans ; Indomethacin ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Pyridines ; adverse effects ; therapeutic use ; Sulfones ; adverse effects ; therapeutic use
3.Severe acute interstitial lung disease induced by crizotinib therapy in a patient with c-Met amplification non-small cell lung cancer.
Youxin JI ; Zhongfa ZHANG ; Keke NIE ; Ketao LAN ; Chuanxin GENG ; Shichao LIU ; Ling ZHANG ; Zongchun ZHANG ; Lei SUN ; Xiao ZOU
Chinese Medical Journal 2014;127(8):1600-1600
4.Sorafenib for advanced hepatocellular carcinoma: a systematic review.
Zou LING-LIN ; Ma LI ; Tian JIN-HUI ; Yang KE-HU
Acta Academiae Medicinae Sinicae 2011;33(1):51-57
OBJECTIVETo evaluate the effectiveness and toxicity of sorafenib for advanced hepatocellular carcinoma.
METHODSAccording to the Cochrane handbook for systematic review, two reviewers independently completed the whole process of literature search, study selection, data collection, and quality assessment. Seven electric databases(PubMed, Cochrane Library, Embase, Chinese Journal Full-text Database, Chinese Biomedical Literature Database, Chinese Scientific and Technical Journal Database, Chinese Medical Association Digital Periodicals Database) were searched and randomized controlled trials (RCT) of sorafenib in the treatment of advanced hepatocellular carcinoma were collected and analyzed.
RESULTSTwo RCT involving 828 patients were finally included. Compared with placebo, sorafenib significantly extended the overall survival and time to radiologic progression and improved the disease control rate. The main adverse effects were systemic, gastrointestinal, and dermatologic symptoms (grade 1 or 2 in severity), although the incidences were significantly higher in sorafenib groups than in control groups.
CONCLUSIONSorafenib is effective and safe for the treatment of advanced hepatocellular carcinoma.
Antineoplastic Agents ; adverse effects ; therapeutic use ; Benzenesulfonates ; adverse effects ; therapeutic use ; Carcinoma, Hepatocellular ; drug therapy ; Humans ; Liver Neoplasms ; drug therapy ; Niacinamide ; analogs & derivatives ; Phenylurea Compounds ; Pyridines ; adverse effects ; therapeutic use
5.Comparison of the efficacy and safety of capecitabine or tegafur, gimeracil and oteracil potassium capsules combined with oxaliplatin chemotherapy regimens in the treatment of advanced gastric cancer.
Yiyuan WAN ; Hongxia HUI ; Xiaowei WANG ; Jian WU ; Su'an SUN
Chinese Journal of Oncology 2016;38(1):28-34
OBJECTIVETo observe the efficacy and safety of chemotherapy regimens oxaliplatin combined with capecitabine (CAPOX) or oxaliplatin combined with tegafur, gimeracil and oteracil potassium capsules (S-1)(SOX), and to investigate the value of expression of thymidine phosphorylase (TP) and dihydropyrimidine dehydrogenase (DPD) proteins in tumor tissue for predicting the efficacy of CAPOX and SOX regimens in advanced gastric cancer patients.
METHODSA total of 107 newly-diagnosed, stage Ⅲc/Ⅳ gastric cancer patients (no surgical indication, ECOG performance scores 0-2 and expected survival time ≥3 months) were recruited with 101 patients evaluated. The patients were randomly divided into two groups. One was study group in which the patients received CAPOX regimen. The other was control group received SOX regimen. Each patient received four cycles, at least two cycles chemotherapy every three weeks and followed up until death or lost. Tumor biopsies were obtained by gastroscopy for immunohistochemical examination of the expression of TP and DPD proteins before chemotherapy. Response rate (ORR), overall survival (OS) and time to tumor progression (TTP) of the patients were assessed.
RESULTSThe objective response rate (ORR) of the study and control groups was 49.0% (5/51) vs. 46.0% (23/50), respectively (P>0.05). The overall survival (OS) was 357.36±24.69 days in the study group and 349.87±22.63 days in the control group, and the time-to-progression (TTP) was 216.75±19.32 days in the study group and 220.54±18.47 days in the control group (P>0.05 for both). Stratified analysis showed that the ORR of TP-positive patients in the study group was significantly higher than that in the control group (72.0 % vs. 41.7 %, P=0.032). There was no significant difference in ORR between the TP-negative patients in the study and control groups (26.9% vs. 50.0%, P=0.087), while the ORR of DPD-positive patients in the control group was significantly higher than that of the study group (51.9% vs. 34.6%, P=0.046). There was no significant difference in the ORR between DPD-negative patients in the study and control groups (64.0% vs. 39.1%, P=0.084). The follow-up showed that the OS (378.42±22.56 days) and TTP (271.77±24.92 days) in the TP-positive patients of the study group were significantly longer than those of the control group (OS: 326.57±19.84 days, and TTP: 229.13±22.68 days)( P<0.05). The OS was 371.25±23.97 days and TTP was 264.66±21.36 days in the DPD-positive patients of control group, significantly longer than those of the study group (OS: 334.73±21.47days, and TTP: 208.58±20.70 days) (P<0.05). But there was no significant difference in the OS and TTP between the TP- and DPD-negative patients in the two groups (P>0.05). In respect of adverse events, both the rates of hematological and non-hematological toxicities were low and similar between the two groups (P>0.05), and well-tolerated by the patients.
CONCLUSIONSBoth CAPOX and SOX regimens are effective chemotherapeutic protocols in treatment of patients with advanced gastric cancer. The expression levels of TP and DPD in tumor tissue can be used as a predictive factor for the efficacy of capecitabine or tegafur, gimeracil and oteracil potassium capsules combined with oxaliplatin regimens. CAPOX chemotherapy regimen is more suitable for the TP-positive gastric cancer patients, and SOX regimen is more suitable for the DPS-positive gastric cancer patients.
Antineoplastic Agents ; adverse effects ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Capecitabine ; administration & dosage ; adverse effects ; Capsules ; Dihydrouracil Dehydrogenase (NADP) ; metabolism ; Disease Progression ; Humans ; Neoplasm Proteins ; metabolism ; Organoplatinum Compounds ; administration & dosage ; adverse effects ; Oxonic Acid ; administration & dosage ; adverse effects ; Pyridines ; administration & dosage ; adverse effects ; Stomach Neoplasms ; drug therapy ; metabolism ; mortality ; pathology ; Tegafur ; administration & dosage ; adverse effects ; Thymidine Phosphorylase ; metabolism
6.Efficacy of crizotinib for 28 cases of advanced ALK-positive non-small cell lung cancer.
Wenxian WANG ; Zhengbo SONG ; Xinmin YU ; Guangyuan LOU ; Cuiping GU ; Xun SHI ; Jun ZHAO ; Yiping ZHANG ; Email: ZYP@MEDMAIL.COM.CN.
Chinese Journal of Oncology 2015;37(10):784-787
OBJECTIVEThis study aims to evaluate the efficacy and safety of crizotinib for advanced ALK-positive non-small cell lung cancer (NSCLC) patients.
METHODSTwenty-eight patients with advanced ALK-positive NSCLC were given orally crizotinib 250 mg b. i.d., and were followed up to evaluate the therapeutic efficacy and safety.
RESULTSAmong the 28 patients, the objective response rate (ORR) was 71.4% (20/28) and disease control rate (DCR) was 92.9% (26/28). Three patients achieved complete response. Seventeen patients had partial response. The most common drug-related adverse events were mild flickering vision and gastrointestinal reaction. Eleven patients experienced flickering vision. Nine patients had nausea and vomiting. Eight patients had diarrhea. They were all reversible and of grade I or II. Only one patient had grade III myelosuppression. Among the 28 patients, 16 cases were disease-free and 12 cases had progressive disease, with a progression-free survival of 8.2 months.
CONCLUSIONSCrizotinib is effective and tolerable in the treatment of advanced ALK-positive NSLCC. However, its long-term treatment efficacy requires to be further studied.
Antineoplastic Agents ; adverse effects ; therapeutic use ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; enzymology ; pathology ; Diarrhea ; chemically induced ; Disease-Free Survival ; Humans ; Lung Neoplasms ; drug therapy ; enzymology ; pathology ; Nausea ; chemically induced ; Protein Kinase Inhibitors ; adverse effects ; therapeutic use ; Pyrazoles ; adverse effects ; therapeutic use ; Pyridines ; adverse effects ; therapeutic use ; Receptor Protein-Tyrosine Kinases ; Vomiting ; chemically induced
7.Comparison of preemptive analgesia efficacy between etoricoxib and rofecoxib in ambulatory gynecological surgery.
Wei LIU ; C C LOO ; H M TAN ; Tie-Hu YE ; Hong-Zhi REN
Acta Academiae Medicinae Sinicae 2004;26(6):666-670
OBJECTIVETo compare the preemptive analgesia efficacy between two cycloxygenase-2 inhibitors, rofecoxib and etoricoxib in the ambulatory uterine evacuation patients.
METHODSIn this randomized, double-blinded, placebo-controlled trial 60 patients were randomly divided into three groups and received a single dose of placebo, rofecoxib 50 mg, or etoricoxib 120 mg, respectively, before operation. Patient's visual analogue score (VAS) was rated postoperatively at 15 min, 30 min, 60 min, time-to-discharge, 6 h and 24 h. Fentanyl (in post-anesthesia care unit) and paracetamol (at home) were supplementary analgesics and the dosage was also recorded. Patient's satisfaction score was rated at 24 h postoperatively.
RESULTSEtoricoxib 120 mg and rofecoxib 50 mg were significantly superior to placebo at 6 h postoperatively (P < 0.05) while there was no significant differences of VAS at other time points. The amounts of Fentanyl used in post-anesthesia care unit were similar in three groups, but paracetamol taken at home was much less in rofecoxib group and etoricoxib group than in placebo group (P < 0.01). Compared to rofecoxib, etoricoxib provided better pain relief after discharge (P < 0.05). The overall pain management satisfaction score was significantly higher in etoricoxib group (96 +/- 7) than in other groups (P < 0.01).
CONCLUSIONPreemptive rofecoxib 50 mg and etoricoxib 120 mg may significantly decrease VAS at 6 h postoperatively, and reduce the usage of analgesics in ambulatory uterine evacuation patients. Etoricoxib 120 mg offeres better pain relief at home compared with rofecoxib 50 mg.
Abortion, Induced ; adverse effects ; Acetaminophen ; therapeutic use ; Adolescent ; Adult ; Ambulatory Surgical Procedures ; Analgesics, Non-Narcotic ; therapeutic use ; Analgesics, Opioid ; therapeutic use ; Cyclooxygenase Inhibitors ; therapeutic use ; Double-Blind Method ; Female ; Fentanyl ; therapeutic use ; Humans ; Lactones ; therapeutic use ; Pain Measurement ; Pain, Postoperative ; prevention & control ; Preoperative Care ; Pyridines ; therapeutic use ; Sulfones ; therapeutic use
8.Therapeutic efficacy and prognostic factors of sorafenib treatment in patients with unresectable primary hepatocellular carcinoma.
Lan ZHANG ; Zheng-gang REN ; Yu-hong GAN ; Yan-hong WANG ; Bo-heng ZHANG ; Yi CHEN ; Xiao-ying XIE ; Nin-ling GE ; Sheng-long YE
Chinese Journal of Oncology 2010;32(8):630-633
OBJECTIVETo evaluate the efficacy and analyze the prognostic factors of sorafenib treatment in patient with unresectable primary hepatocellular carcinoma (HCC).
METHODSDuring the period from December 2005 to March 2009, 50 patients with unresectable primary HCC of Child-Pugh status A were treated with sorafenib (400 mg, Bid). The tumor response was evaluated with CT or MRI imaging every 6 - 8 weeks according to the RECIST criteria. The overall survival (OS) and time to progression (TTP) were defined as the time from administration of sorafenib to the death or the last follow up and were evaluated by Kaplan-Meier method.
RESULTSThere was no PR or CR, but 28 patients (56.0%) achieved stable disease. The median follow up time was 15 months with a median OS of 14 months and median TTP of 4 months. The common adverse events were dermal reaction (68.0%, 34/50), diarrhea (52.0%, 26/50), hypertension (4.0%, 2/50), hair loss (14.0%, 7/50), myelosuppression (16.0%, 8/50), and liver dysfunction (20.0%, 10/50). However, most of the drug-related adverse events were grade I-II and reversible. The patients with lower tumor burden and without distant metastasis had better prognosis.
CONCLUSIONSoafenib is effective for unresectable primary HCC with tolerable toxicity. Tumor stage is a predominant prognostic factor.
Adult ; Aged ; Alopecia ; chemically induced ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Benzenesulfonates ; adverse effects ; therapeutic use ; Carcinoma, Hepatocellular ; drug therapy ; Chemoembolization, Therapeutic ; methods ; Diarrhea ; chemically induced ; Disease Progression ; Follow-Up Studies ; Humans ; Hypertension ; chemically induced ; Liver Neoplasms ; drug therapy ; Male ; Middle Aged ; Neoplasm Staging ; Niacinamide ; analogs & derivatives ; Phenylurea Compounds ; Pyridines ; adverse effects ; therapeutic use ; Skin Diseases ; chemically induced ; Survival Rate
9.Clinical observation of the treatment with combination of transcatheter arterial chemoembolization and sorafenib for hepatocellular carcinoma with lung metastasis.
Feng DUAN ; Mao-qiang WANG ; Feng-yong LIU ; Zhi-jun WANG ; Peng SONG
Chinese Journal of Oncology 2009;31(9):716-718
OBJECTIVETo evaluate the safety and efficacy of the combination of transcatheter arterial chemoembolization (TACE) and sorafenib in treatment of hepatocellular carcinoma (HCC) with lung metastasis.
METHODSThirty HCC patients with lung metastasis were treated by the combination of TACE and sorafenib between Oct 2006 and May 2008, including 27 men and 3 women. The age of the patients ranged 32 to 73 years old. Sorafenib was administrated orally at 400 mg, twice daily (the less tolerant patients received 200 mg, bid.), if there was no counterindication, at 3 - 4 weeks after TACE, with every 4 weeks as a course of treatment. The efficacy was evaluated at the end of every course of treatment.
RESULTSThe metastatic lesions in the lung were diminished in 6 cases and stable diseases achieved in 8 cases. The primary liver tumors were stable in 22 cases, including 10 cases achieved by TACE before sorafenib treatment. Eight cases had slightly progressed liver tumors and were treated with 1 - 3 times of TACE in combination with sorafenib. Side effects included skin lesions in 7 cases, hair loss in 6 cases, fatigue in 18 cases, diarrhea in 6 cases, anemia and bone marrow suppression in 5 cases, high blood pressure in 2 cases, and gastrointestinal bleeding in 1 case.
CONCLUSIONThe combination of TACE and sorafenib can be used as an effective treatment for hepatocellular carcinoma patients with lung metastasis, which may stabilize the disease in some patients.
Adult ; Aged ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Benzenesulfonates ; adverse effects ; therapeutic use ; Carcinoma, Hepatocellular ; drug therapy ; secondary ; therapy ; Chemoembolization, Therapeutic ; methods ; Combined Modality Therapy ; Diarrhea ; chemically induced ; Fatigue ; chemically induced ; Female ; Humans ; Liver Neoplasms ; drug therapy ; pathology ; therapy ; Lung Neoplasms ; drug therapy ; secondary ; therapy ; Male ; Middle Aged ; Niacinamide ; analogs & derivatives ; Phenylurea Compounds ; Pyridines ; adverse effects ; therapeutic use
10.Clinical observation of transarterial chemoembolization combined with sorafenib for advanced hepatocellular carcinoma.
Li-tao XU ; Zhen CHEN ; Jun-hua LIN ; Zhen-hua ZHOU ; Hao CHEN ; Zhi-qiang MENG ; Lu-ming LIU
Chinese Journal of Oncology 2010;32(9):703-705
OBJECTIVETo observe the efficacy and side effects of transarterial chemoembolization (TACE) combined with sorafenib for advanced hepatocellular carcinoma (HCC).
METHODSForty patients with HCC were treated with sorafenib (400 mg bid) after TACE. The efficacy was evaluated according to RECIST 1.1 criteria, and side effects were assessed by NCI CTC 3.0 criteria.
RESULTSAmong the forty cases, one case achieved complete remission (CR), seven cases achieved partial remission (PR), nineteen cases achieved stable disease (SD) and thirteen cases had progressive disease (PD). The disease control rate (DCR) was 67.5%. The overall survival time was 1 - 18 months, and 1-year survival rate was 54.0%. The major adverse events were hand-foot skin reaction, diarrhea and thrombocytopenia.
CONCLUSIONThe combined therapy of TACE and sorafenib is effective and well tolerated for advanced HCC.
Adolescent ; Adult ; Aged ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Benzenesulfonates ; adverse effects ; therapeutic use ; Carcinoma, Hepatocellular ; pathology ; therapy ; Chemoembolization, Therapeutic ; adverse effects ; Combined Modality Therapy ; Diarrhea ; etiology ; Disease Progression ; Doxorubicin ; administration & dosage ; adverse effects ; analogs & derivatives ; Female ; Follow-Up Studies ; Humans ; Liver Neoplasms ; pathology ; therapy ; Male ; Middle Aged ; Neoplasm Staging ; Niacinamide ; analogs & derivatives ; Organoplatinum Compounds ; administration & dosage ; adverse effects ; Phenylurea Compounds ; Pyridines ; adverse effects ; therapeutic use ; Remission Induction ; Survival Rate ; Thrombocytopenia ; etiology ; Young Adult