scholarly journals Palliative chemotherapy in carcinoma nasopharynx

2019 ◽  
Vol 08 (03) ◽  
pp. 173-177
Author(s):  
Vijay M. Patil ◽  
Amit Joshi ◽  
Vanita Noronha ◽  
Vikas Talreja ◽  
Vijai Simha ◽  
...  
Keyword(s):  
Palliative Chemotherapy ◽  
Progression Free Survival ◽  
Utility Analysis ◽  
Free Survival ◽  
State Duration ◽  
Toxicity Analysis ◽  
Rare Malignancy ◽  
Palliative Systemic Chemotherapy ◽  
Systemic Cytotoxic Therapy ◽  
Threshold Utility

Abstract Introduction: Nasopharyngeal carcinoma is a rare malignancy. We conducted an audit of systemic therapies received in palliative setting in carcinoma nasopharynx and studied their outcomes. Methods: Patients who underwent first-line palliative systemic chemotherapy between January 2014 and April 2017 for carcinoma nasopharynx at the department of medical oncology at authors' institute were selected for this analysis. Toxicities, responses, progression-free survival (PFS), and overall survival (OS) were analyzed. In addition, a Quality-Adjusted Time without Symptoms or Toxicity analysis with threshold utility analysis was performed. Results: Fifty-one patients were included in this analysis. The indication of palliative chemotherapy was locoregionally recurrent disease in 25 (49.0%) patients and metastatic disease in 26 (51.0%) patients. The overall response rate was 62.0% (n = 33). The median PFS was 225 days (95% confidence interval [CI]: 164–274 days) and median OS was 513 days (95% CI: 286–931 days). The restricted mean TOX state duration was 2.6 days (95% CI: 0.3–4.9), restricted mean TWiST duration was 219.2 days (95% CI: 184.0–254.4), and restricted mean REL duration was 74.3 days (95% CI: 38.1–110.4). Conclusion: Systemic cytotoxic therapy in nasopharyngeal cancers is associated with high response rates and clinically meaningful PFS; with low duration of time spent in adverse events.

Comparison of efficacy and safety of second-line palliative chemotherapy with paclitaxel plus raltitrexed and paclitaxel alone in patients with metastatic gastric adenocarcinoma: A randomized phase II trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4054-4054 ◽  
Author(s):  
Xiaoying Zhao ◽  
Weijian Guo ◽  
Zhiyu Chen ◽  
Xiaowei Zhang ◽  
Xiaodong Zhu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Palliative Chemotherapy ◽  
Progression Free Survival ◽  
Second Line ◽  
Peripheral Neurotoxicity ◽  
Free Survival ◽  
Randomized Phase Ii ◽  
P 75 ◽  
Grade 3

4054 Background: Paclitaxel is a microtubule stabilizing agent that has been the standard second line chemotherapy in the treatment of advanced gastric cancer. This study was designed to find out the clinical outcome of paclitaxel plus raltitrexed regimen as second line treatment in MGC patients. Methods: In an open, randomized, multi centers phase II clinical trial , 148 patients were randomly assigned and treated with either RP (raltitrexed 3 mg/m2 d1 and paclitaxel 135mg/m2 d1,3w) or P (paclitaxel 135mg/m2 d1,3w) as second-line palliative chemotherapy. The primary endpoint is PFS, secondary endpoint is ORR, OS and safety. Results: In 148 randomly assigned and treated patients (RP = 73; P = 75), the majority of patients were males (94 vs. 54). Progression free survival has a tendency to be prolonged with RP versus P (2.7m vs. 1.7m, p = 0.148). Overall survival also has a tendency to be prolonged with RP versus P (10.2m vs. 6.1m, p = 0.140). Overall response rate was equal with RP versus P (6.8% vs.4.0%, p = 0.72). DCR in the RP group was 56.2%, P group was 36.0%. Grade 3 to 4 treatment-related adverse events occurred in 36.2% (RP) v 28.2% (P) of patients. Frequent grade 3 to 4 toxicities for RP v P were: neutropenia (11.0% v 4.0%), anemia (1.4% v 4.0%), thrombocytopenia (1.4% v 5.3%), and all grade peripheral neurotoxicity (12.3% v 17.3%),all grade elevated aminotransferase (27.4% v 14.1%). Subgroup analysis shows if the disease combined with ascites or peritoneal involved , OS of RP regimen is more longer (p = 0.05). Conclusions: Second-line palliative chemotherapy with paclitaxel plus raltitrexed provides a tendency to prolong PFS and OS, and the patients with ascites or peritoneal involved may get benifits from combined chemotherapy, which needs to be confirmed by larger sample studies. Clinical trial information: NCT02072317.

Pharmacogenetic Profiling and Clinical Outcome of Patients With Advanced Gastric Cancer Treated With Palliative Chemotherapy

2006 ◽  
Vol 24 (12) ◽  
pp. 1883-1891 ◽  
Author(s):  
Annamaria Ruzzo ◽  
Francesco Graziano ◽  
Kazuyuki Kawakami ◽  
Go Watanabe ◽  
Daniele Santini ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Clinical Outcomes ◽  
Palliative Chemotherapy ◽  
Progression Free Survival ◽  
Free Survival ◽  
Innovative Strategy ◽  
Homozygous Genotype ◽  
Group 2 ◽  
Group 1

Purpose To investigate whether polymorphisms with putative influence on fluorouracil/cisplatin activity are associated with clinical outcomes of patients with advanced gastric cancer (AGC). Patients and Methods Peripheral blood samples from 175 prospectively enrolled AGC patients treated with fluorouracil/cisplatin palliative chemotherapy were used for genotyping 13 polymorphisms in nine genes (TS, MTHFR, XPD, ERCC1, XRCC1, XRCC3, GSTPI, GSTTI, GSTMI). Genotypes were correlated to response and survival. Results The overall response rate was 41%, the median progression-free survival (PFS) was 24 weeks (range, 4 to 50 weeks), and the median overall survival (OS) was 39 weeks (range, 8 to 72+ weeks). Chemoresistance and poor survival were significantly associated with TS 5′-UTR 3G-genotype (2R/3G, 3C/3G, 3G/3G) and GSTP1 105 A/A homozygous genotype. Sixty-one patients (35%) did not show any of these risk genotypes (group 0), 57 patients (32.5%) showed one of the two risk genotypes (group 1), and 57 patients (32.5%) showed both risk genotypes (group 2). Median PFS and OS in group 0 patients were 32 weeks (range, 8 to 50 weeks) and 49 weeks (range, 18 to 72+ weeks), respectively. Group 1 and group 2 patients showed significantly worse PFS (median, 26 weeks [range, 6 to 44 weeks] and 14 weeks [range, 4 to 38 weeks], respectively) and worse OS (median, 39 weeks [range, 10 to 58 weeks] and 28 weeks [range, 8 to 56 weeks]), respectively, than group 0 patients. This adverse effect was retained in multivariate analysis. Conclusion Specific polymorphisms may influence clinical outcomes of AGC patients. Selecting palliative chemotherapy on the basis of pretreatment genotyping may represent an innovative strategy that warrants prospective studies.

Resting palliative chemotherapy in patients with gastric cancer.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 122-122
Author(s):  
Hee Yeon Lee ◽  
Young Seon Hong ◽  
Hae Myung Jeon ◽  
Cho Hyun Park ◽  
Kyo Young Song ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Progressive Disease ◽  
Palliative Chemotherapy ◽  
Recurrent Disease ◽  
Progression Free Survival ◽  
Complete Response ◽  
Palliative Surgery ◽  
Free Survival ◽  
Best Response ◽  
Palliative Setting

122 Background: In gastric cancer, platinum and fluorouracil combination chemotherapy (CTx) is commonly used. But the optimal duration of CTx in palliative setting is not known. Thus, we reviewed the pts who rested CTx despite of persistent disease control. Methods: From Mar 2007 to Feb 2012 at Seoul St. Mary’s hospital, we retrospectively reviewed pts as follows; (1) had metastatic or recurrent gastric cancer, (2) received 9 cycles of FOLFOX as 1st-line, (3) had no progressive disease (PD) and rested after completion of 9th cycle. Results: Total 25 pts were reviewed. Median age was 54 (36~77) and 15 pts (60%) were male. 13 pts (52%) had recurrent disease and 12 metastatic initially. All pts were treated with oxaliplatin 100 mg/m2, leucovorin 400 mg/m2 on day 1 and 5-FU 1200 mg/m2 on day 1-2 every 2 weeks. All pts had metastasis; carcinomatosis peritonei (CP, 56%), lymph node (36%), liver (20%) and bone (8%). Nine pts (48%) had non-measurable lesions and 3 no evidence of disease (NED) on CT after palliative surgery. Response evaluation was done every 3 cycles. Among 22 pts with evaluable disease, 5 (20%) showed complete response (CR), 8 (32%) partial response (PR), 2 (8%) stable disease (SD) and 7 (28%) non-CR/non-PD as best response. Median progression free survival (PFS) was 14.2 m (95% CI, 6.6-21.9). The PFS in CP vs. non-CP was 9.9 vs. 21.5 m (log rank P = .037). And PFS according to best response were as follows; 25.5 m in CR + NED group, 15.7 PR, 13.4 non-CR/non-PD and 4.3 SD (log rank P = .014). Other factors did not seem to affect PFS. Conclusions: This study suggested that resting CTx in selected pts would be reasonable in gastric cancer. Especially the presence of CP and the grade of response seemed to be important in patient selection.

Impact of tumor location on effectiveness of first-line 5-FU-based palliative doublet chemotherapy in patients with metastatic gastroesophageal cancer.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 240-240
Author(s):  
Suleyman Yasin Goksu ◽  
Rodrigo Alterio ◽  
Elizabeth McGehee ◽  
Muhammad Shaalan Beg ◽  
Syed Mohammad Ali Kazmi ◽  
...  
Keyword(s):  
Peritoneal Metastasis ◽  
Primary Tumor ◽  
Palliative Chemotherapy ◽  
Progression Free Survival ◽  
Safety Net ◽  
Tumor Location ◽  
Molecular Characteristics ◽  
First Line ◽  
Free Survival ◽  
Doublet Chemotherapy

240 Background: While gastroesophageal cancers with different primary tumor locations can have distinct molecular characteristics and clinical outcomes, the efficacy of palliative chemotherapy in tumors with different locations is unknown. Using primary tumor location as a surrogate for molecular subtype, we investigated the differential efficacy of first-line doublet chemotherapy in metastatic gastroesophageal adenocarcinomas. Methods: We performed a retrospective review of patients with metastatic gastroesophageal adenocarcinoma who received first-line palliative chemotherapy at the University of Texas Southwestern Medical Center and the Dallas County Safety Net Parkland Hospital diagnosed between 2011-2019. Cases were identified using cancer registries. We categorized the tumor location as proximal or distal based on endoscopy and imaging studies. Disease response was assessed on the first staging scan and classified as ‘disease shrinkage, stability, or progression.’ Overall and progression-free survival were evaluated using Kaplan-Meier and Cox proportional hazards methods. Results: 99 patients were identified; 58.6% had proximal tumors. Patients with proximal tumors were more likely to be white (38% vs. 13%, p = 0.008) and older with age ≥ 50 years (71% vs. 51%, p = 0.04) and less likely to have peritoneal metastasis (48% vs. 78%, p = 0.003) than distal tumors. Patients with proximal tumors had a higher disease shrinkage than patients with distal tumors (53% vs. 21%, p = 0.004). Patients with proximal tumors also had better overall survival (median 12.5 vs. 8.7 months) and progression-free survival in response to 5-FU based chemotherapy (median 5 vs. 4 months) compared to patients with distal tumors, but this was not statistically significant. On multivariable analysis, tumor location was not independently predictive of progression-free survival after adjusting for age, gender, presence of signet rings, diffuse, intestinal histology, and peritoneal metastasis (HR 1.22 95% CI 0.74-2.00), but pretreatment albumin was (HR 0.63 95% CI 0.43-0.94). Conclusions: Proximal gastroesophageal cancers have a better clinical response to first-line 5FU containing chemotherapy than distal cancers. Currently, there is no platform to determine molecular subgroups that is commercially available. Until testing for this becomes available, differences in response rates to palliative chemotherapy in gastroesophageal cancers with different anatomical locations should be recognized and studied further.

Phase II trial evaluating imatinib (I) in patients (pts) with anaplastic thyroid carcinoma (ATC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6057-6057
Author(s):  
H. T. Ha ◽  
J. S. Lee ◽  
S. Urba ◽  
R. J. Koenig ◽  
J. Sisson ◽  
...  
Keyword(s):  
Performance Status ◽  
Progression Free Survival ◽  
Distant Metastases ◽  
Complete Response ◽  
Selective Inhibition ◽  
Anaplastic Thyroid Carcinoma ◽  
Response To Treatment ◽  
Free Survival ◽  
Rare Malignancy

6057 Background: There is no standard treatment for ATC. Response to doxorubicin ranges between 5–22%; median survival ranges between 3–6 months. Affymetrix gene chip showed PDGFR overexpression in ATC. In p53 mutated/deficient ATC cell lines, c-Abl is overexpressed, and selective inhibition of c-Abl resulted in cytostatic effect. (I) inhibits tyrosine kinase activity of Bcr-Abl and PDGF. We hypothesize that ATC that overexpress PDGFR or Abl will respond to (I). Methods: Pts ≥ 18 years old with histologically confirmed ATC, overexpressing PDGFR or c-Abl by immunohistochemistry who had measurable disease were eligible. Pts must have Zubrod performance status ≤ 1, and adequate hepatic and renal function. Prior chemotherapy, chemoradiation, radiation therapy, or surgery must have been completed at least 28 days prior to registration. (I) was administered at 400mg orally twice daily without drug holiday. Response to treatment was assessed after every 8 weeks. Pts with complete response (CR)/partial responses (PR)/stable disease (SD) were treated until disease progression. The study was terminated early due to poor accrual. Results: From February 2004 to May 2007, eleven pts from our institution were enrolled and were started on (I) (6 men; 5 women) with a median age of 63 years (ranges 53–80). At baseline, 4/11 pts (36%) had locoregional disease, 5/11 pts (45%) had distant metastases, and 2/11 pts (18%) had both. Nine pts had prior chemoradiation, and 7 pts had thyroidectomy. Out of 11 pts, 8 were evaluable for response; 3 were excluded for lack of follow up radiological evaluation. The overall responses at 8 weeks were CR 0/8; PR 2/8 (25%); SD 4/8 (50%); and PD 2/8 (25%). The median time to follow up was 26 months (ranges 23–30 months). The estimate of 6-month progression free survival was 27% (95% CI, 7–54%). The estimate of 6-month overall survival was 46% (95% CI, 17–71%). The most common G3 toxicity was lymphopenia in 45%; other G3 toxicities included edema (27%), anemia (18%), and hyponatremia (18%). There was no G4 or higher or treatment related death. Conclusions: (I) appears to have activity in advanced ATC and is well tolerated. Due to difficulty of accruing pts with a rare malignancy at a single institution, investigation of (I) in ATC may be warranted in a multi-institution setting. No significant financial relationships to disclose.

Clinical characteristics and outcomes of metastatic or recurrent gastric cancer with high progranulin expression in patients who had received palliative chemotherapy.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 83-83
Author(s):  
Dong-Hoe Koo ◽  
Ingu Do ◽  
Tae-Kyung Yoo ◽  
Sukjoong Oh ◽  
Yun-Gyoo Lee ◽  
...  
Keyword(s):  
Palliative Chemotherapy ◽  
Progression Free Survival ◽  
Cell Types ◽  
Autocrine Growth ◽  
Free Survival ◽  
Growth And Survival ◽  
Response To Chemotherapy ◽  
Metastatic Sites

83 Background: Progranulin (PGRN), characterized as an autocrine growth and survival factor, is known to stimulate the tumorigenesis and proliferation of several cancer cell types. However, little is known about the prognostic role of PGRN in metastatic or recurrent gastric cancers (MRGCs). Methods: A retrospective analysis was performed on patients with MRGCs who had received palliative chemotherapy between January 2010 and March 2014. PGRN expression in tumor cells by immunohistochemical staining was calculated as the product of proportion (0 = none; 1 ≤ 25%; 26% ≤ 2 ≤ 50%; 3 > 50%) and intensity score (0, no staining; 1, weak; 2, moderate; 3, strong), and categorized as high expression (Score ≥ 4) or low expression ( < 4). Results: A total of 101 patients were analyzed with the median age of 57 years (range, 24–79) at first-line chemotherapy, and 66 patients (65%) were male. Twenty-three patients (23%) had high PGRN expression tumors, and they were almost younger patients (≤ 65 years, 96%). In terms of metastatic sites, the patients with high PGRN tumors had more liver metastasis (30% vs. 17%), and the patients with low PGRN had more bone metastasis (10% vs. 4%). There were no significant differences in the proportion of patients with a response to chemotherapy (32% vs 38%) between patients with high or low PGRN tumors. The median follow-up duration of surviving patients was 54.8 months (range 34.5-81.4 months). Overall, 90 patients (89%) died, and a median overall survival (OS) and progression free survival (PFS) were 13.1 months (95% CI, 9.5–16.8 months) and 5.6 months (95% CI, 4.7-6.5), respectively. The PFS and OS were not statistically different between patients with high PGRN tumors and those that were low PGRN (median PFS 5.2 vs 5.9 and OS 14.9 vs 13.0 months, P = 0.471 and 0.927, respectively). In addition, multivariate analysis showed that PGRN expression was not a prognostic factor in both PFS and OS after adjusting for possible confounding factors including sex, age, performance, histopathology and number of metastasis. Conclusions: There was no relationship between PGRN expression and response to chemotherapy or prognosis in patients with MRGCs.

Efficacy and safety of laterally extended endopelvic resection for the pelvic side wall gynecologic tumors: A four-year prospective cohort study with historical comparison.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6092-6092
Author(s):  
Haerin Paik ◽  
Soo Jin Park ◽  
Hee Seung Kim ◽  
Jae-Weon Kim
Keyword(s):  
Cervical Cancer ◽  
Palliative Chemotherapy ◽  
Recurrent Disease ◽  
Progression Free Survival ◽  
Recurrence Free Survival ◽  
Efficacy And Safety ◽  
Recurrent Cervical Cancer ◽  
Free Survival ◽  
Historical Comparison ◽  
Laterally Extended Endopelvic Resection

6092 Background: Although laterally extended endopelvic resection (LEER) has been introduced to control the pelvic sidewall tumors, there is a lack of evidence about its efficacy and safety despite high skillful procedure, compared with the other treatments. Thus, we performed a prospective cohort study with historical comparison for four years. Methods: One gynecologic oncologist performed LEER consecutively for patients with the pelvic sidewall tumors between March 2014 and July 2018. We compared clinicopathologic characteristics and survival between patients who received primary LEER and with those treated with other treatments. Results: We enrolled 37 patients treated with LEER. Among them, 22 (59.5%) and 15 (40.5%) had recurrent and primary disease. Among perioperative outcomes, there was more estimated blood loss, and hospitalization was longer in recurrent disease and previous surgery (p < 0.05). In recurrent disease, previous progression-free survival < 8 months was related to poor recurrence-free survival after LEER (median, 5.4 vs. 10.2 months; p < 0.05). When LEER was applied for the first recurrence of cervical cancer, recurrence-free survival and overall survival after treatment seemed to be longer in LEER (n = 9) than in palliative chemotherapy (n = 27) without statistical significance (median, 12.2 vs. 4.7 months and 23.2 vs. 12.4 months; p = 0.13 and p = 0.63). In 15 patients with primary locally advanced cervical cancer, LEER after partial response to neoadjuvant chemotherapy showed longer progression-free survival than LEER after stable or progressive disease to neoadjuvant chemotherapy and primary radiotherapy (p = 0.012). After LEER, grade 3 and 4 complications developed in 15 (23.1%) and 2 (3.1%) patients. Conclusions: Compared with palliative chemotherapy, LEER followed by palliative chemotherapy may improve progression-free survival in patients with recurrent cervical cancer located in the pelvic sidewall. If possible, it is more effective to apply LEER without preceding palliative chemotherapy for recurrent cervical cancer located in the pelvic sidewall.

scholarly journals Impact of Standardized Allergen-RemovedRhus vernicifluaStokes Extract on Advanced Adenocarcinoma of the Ampulla of Vater: A Case Series

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Woncheol Choi ◽  
Soomin An ◽  
Eunmi Kwon ◽  
Wankyu Eo ◽  
Sanghun Lee
Keyword(s):  
Evaluation Criteria ◽  
Case Series ◽  
Progression Free Survival ◽  
Final Analysis ◽  
Complete Response ◽  
Ampulla Of Vater ◽  
Free Survival ◽  
Rhus Verniciflua ◽  
Rare Malignancy

Background. Adenocarcinoma of the ampulla of Vater (AAV) is a rare malignancy that has a better prognosis than other periampullary cancers. However, the standard treatment for patients with relapsed or metastatic AAV has not been established. We investigated the clinical feasibility of standardized allergen-removedRhus vernicifluastokes (aRVS) extract for advanced or metastatic AAV.Patients and Methods. From July 2006 to April 2011, we retrospectively reviewed all patients with advanced AAV treated with aRVS extract alone. After applying inclusion/exclusion criteria, 12 patients were eligible for the final analysis. We assessed the progression-free survival (PFS) and overall survival (OS) of these patients during the follow-up period.Results. The median aRVS administration period was 147.0 days (range: 72–601 days). The best tumor responses according to Response Evaluation Criteria in Solid Tumors were as follows: two with complete response, two with stable disease, and eight with progressive disease. The median OS was 15.1 months (range: 4.9–25.1 months), and the median PFS was 3.0 months (range: 1.6–11.4 months). Adverse reactions to the aRVS treatment were mostly mild and self-limiting.Conclusions. Prolonged survival was observed in patients with advanced AAV under the treatment of standardized aRVS extract without significant adverse effects.

A phase II open-label trial of dacomitinib monotherapy in patients with HER2-positive advanced gastric cancer after failure of at least one prior chemotherapy regimen.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 54-54 ◽  
Author(s):  
Do-Youn Oh ◽  
Keun-Wook Lee ◽  
Jae Yong Cho ◽  
Won Ki Kang ◽  
Sun Young Rha ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Skin Rash ◽  
Palliative Chemotherapy ◽  
Chemotherapy Regimen ◽  
Xenograft Model ◽  
Progression Free Survival ◽  
Antitumor Effects ◽  
Free Survival ◽  
Ecog Ps

54 Background: HER2 is a clinically relevant therapeutic target in gastric cancer. Trastuzumab plus chemotherapy has improved patients’ survival in HER2 (+) advanced gastric cancer (AGC). Pan-HER inhibitor shows significant antitumor effects in in vitro and xenograft model of HER2 (+) gastric cancer. The aim of this study was to find the efficacy/safety of dacomitinib, a irreversible pan-HER tyrosine kinase inhibitor by Pfizer, in HER2 (+) AGC patients. Methods: We enrolled AGC patients with HER2 FISH (+) or HER2 IHC 3+ who were treated with at least one prior palliative chemotherapy regimen and with ECOG PS 0-2, normal cardiac ejection fraction. Patients were treated with dacomitinib 45 mg once daily continuously every 4 weeks. Response was evaluated every 8 weeks using RECIST v1.1 and safety was assessed with CTCAE v4.0. The primary endpoint was 4 month-progression free survival rate (4m-PFS). PK and PD study were also conducted. Results: A total of 27 patients were enrolled. The median age was 61 (range: 43-80). Twenty two patients were male. The ECOG PS was 0 in 9 patients, 1 in 16, and 2 in 2. The number of prior palliative chemotherapy regimen was 1 in 7 patients (25.9%), 2 in 9 (33.3%), more than 3 in 11 (40.7%). Six patients received prior anti-HER2 therapy (trastuzumab 2, lapatinib 2, lapatinib or placebo in clinical trial 2) A total of 80 cycles were delivered (median 2 cycles per patient, range: 1-6). The 4m-PFS was 22.2 % and median progression-free survival was 2.1 months (95% CI: 2.3-3.4) There was 2 PR, 9 SD and 16 PD, resulting in 7.4 % response rate (95% CI: 0-17.5%) and 40.7 % disease control rate (95% CI: 21.9-59.6%). Median overall survival was 7.1 months (95% CI: 4.4-9.8). The most common toxicities were skin rash, diarrhea, and fatigue, but most of them were grade ½. Grade 3 skin rash was observed in 3 patients. There was no treatment-related death. Conclusions: Considering the heavily pretreated nature of enrolled patients, the dacomitinib is active and safe treatment option in HER2 (+) AGC patients. The results of PK and PD studies will be also presented at the meeting. (ClinicalTrials.gov: NCT01152853 )

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