1.Single-center study of different treatment for advanced or unresectable angiosarcoma patients.
Rui Qing PENG ; Bu Shu XU ; Yuan Yuan LIU ; Qian Qiong YANG ; Qiu Zhong PAN ; Xing ZHANG
Chinese Journal of Oncology 2023;45(1):74-81
Objective: To evaluate the efficacy and safety of different medical treatment in advanced or unresectable angiosarcoma. Methods: This study was a single-center retrospective clinical study. Fifty-five advanced or unresectable angiosarcoma patients treated in Sun-Yat Sen University Cancer Center from January 2005 to August 2020 were enrolled. There were 34 patients who received first-line doxorubicin-based chemotherapy (doxorubicin group), 12 patients received first-line doxorubicin or liposome doxorubicin plus paclitaxel or albumin bound paclitaxel chemotherapy (combination therapy group), and 4 patients received first-line paclitaxel-based treatment (paclitaxel group). There were 6 patients who received anti-angiogenesis targeted therapy, another 2 patients received anti-PD-1 antibody plus anti-angiogenesis targeted therapy. Targeted therapy and immunotherapy plus targeted therapy included 5 cases of first-line therapy and 3 cases of second-line therapy. The therapeutic effect was evaluated by RECIST 1.1 standard. The adverse reactions were evaluated by CTCAE4.0 standard. Kaplan-Meier survival analysis was evaluated with Log rank test. Cox proportional hazard model was used to analyze the influencing factors. Results: There were 18 patients achieved partial response (PR) in 34 patients in the doxorubicin group, median progression-free survival (mPFS) was 4.5 months, and median overall survival (mOS) was 15 months. Four patients achieved PR in 12 patients in the combination therapy group, mPFS and mOS were 4 months and 19 months. Two patients achieved PR in 4 patients in the paclitaxel group, mPFS and mOS were 3 months and 9 months. However, only 1 in 6 patients achieved PR for anti-angiogenesis targeted therapy, mPFS and mOS were 3 months and 16 months. Two patients who received anti-PD-1 immunotherapy combined with anti-angiogenesis targeted therapy acquired PR for 17 months and more than 16 months. Median PFS (7.5 months) were longer in those with primary liver, lung and spleen angiosarcoma than in those with other primary site (3.0 months, P=0.028). The mOS (20 months) was longer in females than that in males (12 months, P=0.045). Primary tumor site, sex, age and treatment were not independent prognostic factors for angiosarcoma patients (P>0.05). Grade 3-4 cardiac toxicity was found in 2 patients in the combination therapy group. Conclusions: Doxorubicin-based and paclitaxel-based chemotherapy are the most important treatment for advanced angiosarcoma. Potential efficacy for targeted therapy combined with anti-PD-1 immunotherapy are showed in some patients with long duration of response and moderate adverse event.
Male
;
Female
;
Humans
;
Hemangiosarcoma
;
Retrospective Studies
;
Paclitaxel/adverse effects*
;
Doxorubicin/therapeutic use*
;
Antineoplastic Combined Chemotherapy Protocols/adverse effects*
2.A real-world study on the efficacy and safety analysis of paclitaxel liposome in advanced breast cancer.
Chun Xiao SUN ; Shu Sen WANG ; Jian Bin LI ; Yong Sheng WANG ; Qu Chang OUYANG ; Jin YANG ; Hai Bo WANG ; Xiao Jia WANG ; Wen Yan CHEN ; Peng YUAN ; Min YAN ; Ze Fei JIANG ; Yong Mei YIN
Chinese Journal of Oncology 2023;45(1):88-94
Objective: To explore the application and efficacy of paclitaxel liposome in the treatment of advanced breast cancer among Chinese population in the real world. Methods: The clinical characteristics of patients with advanced breast cancer who received paclitaxel liposome as salvage treatment from January 1, 2016 to August 31, 2019 in 11 hospitals were collected and retrospectively analyzed. The primary outcome was progression free survival (PFS), and the secondary outcome included objective response rate (ORR) and safety. The survival curve was drawn by Kaplan-Meier analysis and the Cox regression model were used for the multivariate analysis. Results: Among 647 patients with advanced breast cancer who received paclitaxel liposome, the first-line treatment accounted for 43.3% (280/647), the second-line treatment accounted for 27.7% (179/647), and the third-line and above treatment accounted for 29.1% (188/647). The median dose of first-line and second-line treatment was 260 mg per cycle, and 240 mg in third line and above treatment. The median period of paclitaxel liposome alone and combined chemotherapy or targeted therapy is 4 cycles and 6 cycles, respectively. In the whole group, 167 patients (25.8%) were treated with paclitaxel liposome combined with capecitabine±trastuzumab (TX±H), 123 patients (19.0%) were treated with paclitaxel liposome alone (T), and 119 patients (18.4%) were treated with paclitaxel liposome combined with platinum ± trastuzumab (TP±H), 108 patients (16.7%) were treated with paclitaxel liposome combined with trastuzumab ± pertuzumab (TH±P). The median PFS of first-line and second-line patients (5.5 and 5.5 months, respectively) were longer than that of patients treated with third line and above (4.9 months, P<0.05); The ORR of the first line, second line, third line and above patients were 46.7%, 36.8% and 28.2%, respectively. Multivariate analysis showed that event-free survival (EFS) and the number of treatment lines were independent prognostic factors for PFS. The common adverse events were myelosuppression, gastrointestinal reactions, hand foot syndrome and abnormal liver function. Conclusion: Paclitaxel liposomes is widely used and has promising efficacy in multi-subtype advanced breast cancer.
Humans
;
Female
;
Breast Neoplasms/chemically induced*
;
Paclitaxel/adverse effects*
;
Liposomes/therapeutic use*
;
Retrospective Studies
;
Treatment Outcome
;
Trastuzumab/therapeutic use*
;
Capecitabine/therapeutic use*
;
Antineoplastic Combined Chemotherapy Protocols/adverse effects*
3.Efficacy and survival outcomes of dose-dense carboplatin plus paclitaxel as neoadjuvant chemotherapy for triple-negative breast cancer.
Yang LIU ; Meng XIU ; Xiang WANG ; Qing LI ; Jia Yu WANG ; Ying FAN ; Qiao LI ; Shan Shan CHEN ; Rui Gang CAI ; Hong Nan MO ; Fei MA ; Yang LUO ; Bing He XU ; Pin ZHANG
Chinese Journal of Oncology 2022;44(2):178-184
Objective: To evaluate the efficacy and survival outcomes of dose-dense (biweekly) carboplatin plus paclitaxel (PC) as neoadjuvant chemotherapy (NAC) in triple-negative breast cancer (TNBC), and to explore an optimal neoadjuvant chemotherapy regimen for TNBC. Methods: Patients diagnosed as TNBC(cT1-4N0-3M0) in Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Between January 2008 and September 2018 who received dose-dense PC and standard 3-weekly PC as NAC were 1∶1 matched using propensity score matching (PSM) to compare the efficacy, safety and survival outcomes. Results: One hundred of TNBC patients were enrolled (50 patients were divided in dose-dense group, 50 patients in standard group). The objective response rate (ORR) of dose-dense group and standard group were both 90.0% (45/50). The grade 3-4 neutropenia in dose-dense group was less than that of standard group (32.7% vs. 68.0%, P=0.001), while the rate of ALT/AST elevation in dose-dense group was higher than that of standard group (57.1% vs. 32.0%, P=0.012). The pathological complete response (pCR) rates were 34.0% (17/50) in dose-dense group and 38.0% (19/50) in standard group, without statistically significance (P=0.677). The median follow-up time was 55 months (3-150 months). The 5-year recurrence-free survival (RFS) in dose-dense group and standard group were 83.5% and 75.2%, respectively the 5-year overall survival (OS) in dose-dense and standard group were 87.9% and 84.5% the difference were not statistically significant (P=0.322 and 0.647, respectively). Patients with residual disease (tumor size≥1 cm or lymph node positive) had poor prognosis, the 5-year RFS and OS were 59.3% and 68.5%, respectively. Conclusions: Dose-dense PC has similar efficacy with standard 3-weekly PC and has a good safety profile. Since dose-dense regimen can shorten the duration of therapy, it can be an alternative in TNBC.
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
;
Carboplatin/therapeutic use*
;
Humans
;
Neoadjuvant Therapy/adverse effects*
;
Paclitaxel/therapeutic use*
;
Treatment Outcome
;
Triple Negative Breast Neoplasms/pathology*
4.A Comparison of Peri-Procedural Myocardial Infarction between Paclitaxel-Coated Balloon and Drug-Eluting Stent on De Novo Coronary Lesions.
Ae Young HER ; Kyoung Im CHO ; Gillian Balbir SINGH ; Scot GARG ; Yong Hoon KIM ; Bon Kwon KOO ; Eun Seok SHIN
Yonsei Medical Journal 2017;58(1):99-104
PURPOSE: This study compared the impact of paclitaxel-coated balloons (PCB) or drug eluting stents (DES) on peri-procedural myocardial infarction (PMI) on de novo coronary lesion in stable patients. MATERIALS AND METHODS: In this observational study, we compared the incidence of PMI amongst patients with single vessel de novo coronary lesions who underwent treatment with a PCB or DES. Propensity score-matching analysis was used to assemble a cohort of patients with similar baseline characteristics. PMI was classified as myocardial infarction occurring within 48 hours after percutaneous coronary intervention with a threshold of 5 x the 99th percentile upper reference limit of normal for creatine kinase-myocardial band (CK-MB) or troponin T (TnT). RESULTS: One hundred four patients (52 receiving PCB and 52 receiving DES) were enrolled in this study. The peak mean values of CK-MB and TnT were significantly higher in the DES group. There was a significantly higher rate of PMI in the DES group (23.1% vs. 1.9%, p=0.002). Total occlusion of the side-branch occurred in two patients treated with DES, while no patients treated with PCB. In multivariable analysis, DES was the only independent predictor of PMI compared with PCB (odds ratio 42.85, 95% confidence interval: 3.44–533.87, p=0.004). CONCLUSION: Treatment with a PCB on de novo coronary lesion might be associated with a significant reduction in the risk of PMI compared to DES.
Aged
;
Creatine Kinase, MB Form/analysis
;
*Drug-Eluting Stents
;
Female
;
Humans
;
Incidence
;
Kaplan-Meier Estimate
;
Middle Aged
;
Myocardial Infarction/enzymology/epidemiology/etiology/*prevention & control
;
Odds Ratio
;
Paclitaxel/*therapeutic use
;
Percutaneous Coronary Intervention/*adverse effects
;
Propensity Score
;
Time Factors
;
Treatment Outcome
5.Anti-prostate cancer effect of roemerine: An experimental study.
Hong-Bin MA ; Zhong-Shi TIAN ; Shi-Liang GUI ; Wei-Guo CUI ; Wei LI
National Journal of Andrology 2017;23(1):27-33
Objective:
To investigate the anti-prostate cancer (PCa) effect of roemerine in vitro and in vivo in the mouse model of PCa.
METHODS:
We detected the effects of roemerine on the proliferation, apoptosis and migration of PCa cells DU145, LNCaP, PC-3 and 22RV1, screened out the sensitive cell line and constructed a tumor-bearing model in mice for verification of the antitumor efficacy of roemerine in vivo.
RESULTS:
Roemerine inhibited the proliferation and migration of the DU145, LNCaP, PC-3 and 22RV1 cells and induced their apoptosis in different degrees, particularly those of the LNCaP cells. The average tumor weight was less in the roemerine intervention group ([1.99±0.95] g) than in the control ([2.95±1.04] g), the least in the high-dose roemerine (30 mg/kg) plus paclitaxel intervention group ([0.90±0.16] g). The mean heart, liver, and kidney indexes were markedly lower in the roemerine (0.58±0.06, 6.20±0.42 and 1.49±0.33) than in the paclitaxel group (0.66±0.04, 6.99±0.72 and 1.95±0.34), while the mean spleen and thymus indexes were remarkably higher in the former (0.54±0.11 and 0.06±0.01) than in the latter (0.41±0.09 and 0.05±0.01). Pathological staining showed a lower degree of malignancy and metastasis in both the roemerine and the roemerine + paclitaxel intervention group than in the control, as well as a lower degree of visceral injury in the roemerine and roemerine + paclitaxel groups than in the paclitaxel group.
CONCLUSIONS
Roemerine has some anti-PCa effect and alleviates adverse reactions in paclitaxel combination administration.
Alkaloids
;
therapeutic use
;
Animals
;
Antineoplastic Agents, Phytogenic
;
adverse effects
;
therapeutic use
;
Apoptosis
;
drug effects
;
Cell Line, Tumor
;
Cell Movement
;
drug effects
;
Cell Proliferation
;
drug effects
;
Disease Models, Animal
;
Drug Therapy, Combination
;
methods
;
Drugs, Chinese Herbal
;
therapeutic use
;
Male
;
Mice
;
Mice, Nude
;
Paclitaxel
;
adverse effects
;
therapeutic use
;
Prostatic Neoplasms
;
drug therapy
6.Application of paclitaxel as adjuvant treatment for benign cicatricial airway stenosis.
Xiao-Jian QIU ; Jie ZHANG ; Juan WANG ; Yu-Ling WANG ; Min XU
Journal of Huazhong University of Science and Technology (Medical Sciences) 2016;36(6):817-822
Benign cicatricial airway stenosis (BCAS) is a potentially life-threatening disease. Recurrence occurs frequently after endoscopic treatment. Paclitaxel is known to prevent restenosis, but its clinical efficacy and safety is undetermined. Therefore, in this study, we investigated the efficacy and associated complications of paclitaxel as adjuvant treatment for BCAS of different etiologies. The study cohort included 28 patients with BCAS resulting from tuberculosis, intubation, tracheotomy, and other etiologies. All patients were treated at the Department of Respiratory Diseases, Beijing Tian Tan Hospital, Capital Medical University, China, between January 2010 and August 2014. After primary treatment by balloon dilation, cryotherapy, and/or high-frequency needle-knife treatment, paclitaxel was applied to the airway mucosa at the site of stenosis using a newly developed local instillation catheter. The primary outcome measures were the therapeutic efficacy of paclitaxel as adjuvant treatment, and the incidence of complications was observed as well. According to our criteria for evaluating the clinical effects on BCAS, 24 of the 28 cases achieved durable remission, three cases had remission, and one case showed no remission. Thus, the durable remission rate was 85.7%, and the combined effective rate was 96.4%. No differences in outcomes were observed among the different BCAS etiologies (P=0.144), and few complications were observed. Our results indicated that paclitaxel as an adjuvant treatment has greater efficacy than previously reported BCAS treatment methods.
Adolescent
;
Adult
;
Aged
;
Bronchi
;
pathology
;
Chemotherapy, Adjuvant
;
adverse effects
;
Cicatrix
;
complications
;
drug therapy
;
surgery
;
Female
;
Humans
;
Male
;
Middle Aged
;
Paclitaxel
;
administration & dosage
;
adverse effects
;
therapeutic use
;
Postoperative Complications
;
Respiratory Insufficiency
;
drug therapy
;
etiology
;
surgery
;
Tracheal Stenosis
;
drug therapy
;
etiology
;
surgery
;
Tracheotomy
;
adverse effects
7.Hyperthermic intraperitoneal chemotherapy with cisplatin and paclitaxel in advanced ovarian cancer: a multicenter prospective observational study.
Federico COCCOLINI ; Luca CAMPANATI ; Fausto CATENA ; Valentina CENI ; Marco CERESOLI ; Jorge JIMENEZ CRUZ ; Marco LOTTI ; Stefano MAGNONE ; Josephine NAPOLI ; Diego ROSSETTI ; Pierandrea DE IACO ; Luigi FRIGERIO ; Antonio PINNA ; Ingo RUNNEBAUM ; Luca ANSALONI
Journal of Gynecologic Oncology 2015;26(1):54-61
OBJECTIVE: Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) have been recently reported with favorable oncological outcomes as treatment of advanced epithelial ovarian cancer (EOC). The aim of this study was to demonstrate the feasibility of CRS+HIPEC with cisplatin and paclitaxel for the treatment of advanced EOC. METHODS: This is a prospective observational study of 54 patients, from April 2007 to October 2013, with primary or recurrent peritoneal carcinomatosis due to EOC. The mean age was 54.51+/-9.34. Thirty patients (59%) had primary EOC, and 24 patients (41%) had recurrent disease. RESULTS: Mean peritoneal cancer index was 10.11 (range, 0 to 28), complete cytoreduction (CC0) was achieved for 47 patients (87%), CC1 for seven patients (13%). Patients with suboptimal cytoreduction (CC2 and CC3) were not included in the study. The mean stay in intensive care unit was 4.73+/-5.51 days and the mean hospitalization time was 24.0+/-10.03 days. We did not observe any intraoperative death. Seven patients (13%) required additional operations. Three patients (5.6%) died within 30 days from the procedure. Severe complications were seen in 19 patients (35.2%). During the follow-up period, disease recurred in 33 patients (61.1%); the median disease-free survival time was 12.46 months and the median overall survival time was 32.91 months. CONCLUSION: CRS+HIPEC with cisplatin and paclitaxel for advanced EOC is feasible with acceptable morbidity and mortality. Additional follow-up and further studies are needed to determine the effects of HIPEC on long term survival.
Adult
;
Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse effects/*therapeutic use
;
Cisplatin/administration & dosage/adverse effects
;
Combined Modality Therapy
;
Cytoreduction Surgical Procedures/adverse effects/methods
;
Feasibility Studies
;
Female
;
Humans
;
Hyperthermia, Induced/adverse effects/*methods
;
Infusions, Parenteral
;
Kaplan-Meier Estimate
;
Middle Aged
;
Neoplasm Recurrence, Local/drug therapy/surgery
;
Ovarian Neoplasms/*drug therapy/surgery
;
Paclitaxel/administration & dosage/adverse effects
;
Prospective Studies
;
Treatment Outcome
8.Efficacy and tolerability of paclitaxel, ifosfamide, and cisplatin as a neoadjuvant chemotherapy in locally advanced cervical carcinoma.
Giuseppa SCANDURRA ; Giuseppe SCIBILIA ; Giuseppe Luigi BANNA ; Gabriella D'AGATE ; Helga LIPARI ; Stefania GIERI ; Paolo SCOLLO
Journal of Gynecologic Oncology 2015;26(2):118-124
OBJECTIVE: To evaluate the efficacy and tolerability of a neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy in patients with locally advanced cervical carcinoma. METHODS: Patients with histologically confirmed locally advanced cervical carcinoma, aged > or =18 years, were treated with intravenous ifosfamide 5,000 mg/m2 and mesna 5,000 mg/m2, on day 1; intravenous paclitaxel 175 mg/m2 and cisplatin 75 mg/m2, on day 2; every 3 weeks for three cycles. Following chemotherapy, operable patients underwent radical hysterectomy and pelvic lymphadenectomy, and, if necessary, adjuvant radiotherapy. RESULTS: One hundred fifty-two patients with median age 53 years (range, 24 to 79 years), FIGO stage IIB in 126 (89%), were treated with chemotherapy for median 3 cycles (range, 1 to 3). Treatment was delayed or withdrawn in 23 patients (15%). One hundred thirty-nine patients (91%) underwent surgery. Postchemotherapy pathological complete response rate was 18% (25 patients). Postoperative radiotherapy was administered in 100 patients (72%). The 5-year overall survival and progression-free survival were 87.3% (95% confidence interval [CI], 84.5 to 90.3) and 76.4% (95% CI, 73.5 to 79.5), respectively. CONCLUSION: Neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy was feasible and effective in the treatment of locally advanced cervical carcinoma patients with older age and more advanced disease stage than reported in previous studies. Hematological and renal toxicity could be carefully prevented.
Adult
;
Aged
;
Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
;
Carcinoma, Squamous Cell/*drug therapy/mortality/pathology
;
Cisplatin/*administration & dosage/adverse effects
;
Disease Progression
;
Feasibility Studies
;
Female
;
Humans
;
Ifosfamide/*administration & dosage/adverse effects
;
Middle Aged
;
Neoadjuvant Therapy
;
Paclitaxel/*administration & dosage/adverse effects
;
Retrospective Studies
;
Treatment Outcome
;
Uterine Cervical Neoplasms/*drug therapy/mortality/pathology
;
Young Adult
9.Value of postoperative radiochemotherapy for thoracic esophageal squamous cell carcinoma with lymph node metastasis.
Yu LIN ; Junqiang CHEN ; Jiancheng LI ; Jian LIU ; Kunshou ZHU ; Caizhu PAN ; Mingqiang CHEN ; Jianji PAN
Chinese Journal of Oncology 2014;36(2):151-154
OBJECTIVETo retrospectively compare the efficacy of postoperative radiotherapy (RT) alone with that of postoperative radiotherapy with concurrent chemotherapy (CRT) for thoracic esophageal squamous cell carcinoma (EPC) with positive lymph nodes, and to evaluate the clinical value of RT + CRT.
METHODS304 EPC patients underwent esophagectomy with three-field lymph node dissection had pathological lymph node metastases, but no hematogenous distant metastasis. Among them, 140 cases underwent postoperative RT alone, and 164 cases underwent postoperative CRT. The dose of irradiation was 50 Gy, and the chemotherapy regimen was taxol and cis-platinum, and a cycle was 21 days.
RESULTSThe 1-, 3- and 5-year total survival rates of the whole group were 90.1%, 56.6% and 43.3%, respectively, with a median survival time of 49.7 months. The 5-year overall survival rates of the CRT and RT groups were 47.4% and 38.6%, respectively (P = 0.030), with a median survival time of 53.5 and 41.7 months, respectively (P = 0.030). The overall survival rates of the patients who underwent 1, 2, 3, 4 cycles of chemotherapy were 24.4%, 53.0%, 58.1% and 43.3%, respectively (P = 0.007). Among them, the 5-year total survival rate of patients with 2-4 cycles of chemotherapy was significantly better than that of patients who underwent one cycle of chemotherapy (P = 0.001). Univariate analysis showed that number of metastatic lymph nodes, pT stage, therapeutic regimen and number of chemotherapy cycles were significantly correlated with the prognosis of the patients (P < 0.05 for all). Multivariate analysis showed that number of metastatic lymph nodes, pT stage, and number of chemotherapy cycles were independent prognostic factors of the patients (P < 0.05 for all). Early toxic effects including neutropenia, radiation esophagitis, and gastrointestinal effects were significantly more severe in the CRT group than that in the RT group (P < 0.05), however, there were no significant differences of late toxic effects between the two groups (P > 0.05).
CONCLUSIONPostoperative CRT for thoracic EPC with positive lymph nodes can improve the survival rate, with tolerable adverse effects.
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Carcinoma, Squamous Cell ; drug therapy ; pathology ; radiotherapy ; surgery ; Chemoradiotherapy ; adverse effects ; Cisplatin ; administration & dosage ; Esophageal Neoplasms ; drug therapy ; pathology ; radiotherapy ; surgery ; Esophagectomy ; Esophagitis ; etiology ; Female ; Follow-Up Studies ; Humans ; Lymph Node Excision ; Lymphatic Irradiation ; Lymphatic Metastasis ; Male ; Middle Aged ; Neoplasm Staging ; Neutropenia ; chemically induced ; etiology ; Paclitaxel ; administration & dosage ; Particle Accelerators ; Postoperative Period ; Retrospective Studies ; Survival Rate
10.Trastuzumab combined with chemotherapy in patients with HER2-positive chemo-refractory advanced gastric or gastro-esophageal junction adenocarcinoma.
Xiaotian ZHANG ; Yuanhang WU ; Jifang GONG ; Zhihao LU ; Jun ZHOU ; Xicheng WANG ; Ming LU ; Jian LI ; Yanshuo CAO ; Yan LI ; Jie LI ; Lin SHEN
Chinese Journal of Oncology 2014;36(3):223-227
OBJECTIVETo evaluate the efficacy and safety of trastuzumab combined with chemotherapy in the treatment for HER-2-positive chemo-refractory advanced gastric or gastro-esophageal junction adenocarcinoma.
METHODSTwenty consecutive cases of chemo-refractory advanced gastric or gastro-esophageal junction adenocarcinoma treated in Peking University Cancer Hospital between 2009 June and 2013 August were included in this study. The patients with adenocarcinoma were previously confirmed and were eligible if their tumor showed overexpression of HER-2+++ by immunohistochemistry or HER-2 gene amplification-positive by FISH, and if they failed to at least one previous chemotherapy. Response and toxicities were evaluated with RECIST 1.0 and CTC AE 3.0 criteria.
RESULTSThe twenty patients received trastuzumab plus second- or later-line chemotherapy, consisting of nine platinum with fluoropyrimidines, five paclitaxel with fluoropyrimidines, three fluoropyrimidines monotherapy, two irinotecan monotherapy, and one docetaxel monotherapy. In these 20 cases, 3 PR (15.0%) and 10 SD (50.0%) were achieved, with a disease control rate of 65.0%. The median PFS was 6.1 months (95%CI 3.0-9.2) and median OS was 11.1 months (95%CI 8.4-13.7). The median cycle number of Trastuzumab administration was 6.5. The patients treated with Trastuzumab ≥ 6 times had a median OS of 13.8 months, significantly longer than that of 9.5 months in the patients treated <6 times (P < 0.001). The patients treated with Trastuzumab ≥ 6 times had a median PFS of 7.8 months, significantly longer than that of 3.7 months in patients treated <6 times (P = 0.029). Among the 20 cases, loss of appetite (13 cases of grade 1-2), neutropenia (12 cases of grade 1-2 and 3 cases of grade 3-4) and fatigue (9 cases of grade 1-2 and 3 cases of grade 3-4) were the most frequent adverse events. No cardiac events including asymptomatic decreases in LVEF ≥ 10% and no treatment-related death were recorded.
CONCLUSIONSCombination of trastuzumab with chemotherapy is effective and safe in patients with HER2-positive advanced chemo-refractory gastric or gastro-esophageal junction adenocarninoma. However, prospective studies are warranted to further confirm its efficacy and safety.
Adenocarcinoma ; drug therapy ; metabolism ; secondary ; surgery ; Adult ; Aged ; Anorexia ; chemically induced ; Antibodies, Monoclonal, Humanized ; administration & dosage ; adverse effects ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Camptothecin ; administration & dosage ; adverse effects ; analogs & derivatives ; Cisplatin ; administration & dosage ; adverse effects ; Disease Progression ; Disease-Free Survival ; Drug Resistance, Neoplasm ; Esophagogastric Junction ; Fatigue ; chemically induced ; Female ; Follow-Up Studies ; Humans ; Liver Neoplasms ; drug therapy ; secondary ; Male ; Middle Aged ; Neutropenia ; chemically induced ; Paclitaxel ; administration & dosage ; adverse effects ; Pyrimidines ; administration & dosage ; adverse effects ; Receptor, ErbB-2 ; metabolism ; Remission Induction ; Retrospective Studies ; Stomach Neoplasms ; drug therapy ; metabolism ; secondary ; surgery ; Survival Rate ; Trastuzumab

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