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  • American Society of Clinical Oncology (ASCO)  (223)
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  • American Society of Clinical Oncology (ASCO)  (223)
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  • Medicine  (223)
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  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 15_suppl ( 2014-05-20), p. 4070-4070
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
    detail.hit.zdb_id: 2005181-5
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  • 2
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2014
    In:  Journal of Clinical Oncology Vol. 32, No. 15_suppl ( 2014-05-20), p. e15046-e15046
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 15_suppl ( 2014-05-20), p. e15046-e15046
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
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  • 3
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 4097-4097
    Abstract: 4097 Background: The aim of this present phase II study is to explore the safety and efficacy of paclitaxel (T), cisplatin (C), and nimotuzumab (N), a humanized anti-EGFR monoclonal antibody combination (TCN) as first-line treatment in advanced esophageal squamous cell cancer (ESCC). Methods: Patients with histologically confirmed advanced ESCC, measureable tumor, and no prior chemotherapy and radiotherapy except adjuvant treatment were enrolled. Patients were given cisplatin 60mg/m 2 , paclitaxel 175mg/m 2 per 21 days for at least 2 cycles. The nimotuzumab was given 200mg weekly. Radiotherapy was admitted for patients with unresectable local advanced disease after 4 cycle of TCN treatment. The primary endpoints were safety and objective response rate (ORR). The secondary endpoints were progression-free survival (PFS) and over-all survival (OS). The expression of EGFR and ERCC1 were also analyzed by histoimmunochemical staining. Results: Between Mar. 2011 and Dec. 2012, 55 patients with advanced ESCC were enrolled and 53 (96.4%) were eligible for evaluation. The ORR was 54.7% (29/53) and the DCR was 94.3% (50/53). The expression of EGFR and ERCC1 were detected in 46 and 31 patients respectively. The ORR had no relation to both the expression of EGFR (55.3% vs 62.5%, p=0.71) and ERCC1 (41.7% vs 58.3%, p=0.47). As a median follow-up of 15months, the median PFS was 10.5 months (95% CI 8.7 to 12.3 months).The TCN combination treatment was well tolerated and the most common adverse events were alopecia (86.8%), leukopenia (84.9%), anorexia (84.9%), vomiting (73.6%), fatigue (73.6%), pain (66.0%), and anaemia (39.6%). And 18 (34%) patients had Grade 3 to 4 leukopenia. The median OS have not yet been reached. Conclusions: In this study, the ORR, DCR and PFS are superior to previous published studies. The addition of anti-EGFR treatment of nimotuzumab to standard chemotherapy was well tolerated with no serious AEs. But the expression of EGFR by IHC could not predict the outcome of nimotuzumab treatment. A phase III study of TCN followed by radiotherapy in unresectable local advanced ESCC had been designed to explore the survival benefits. Clinical trial information: NCT01336049.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
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  • 4
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. e15573-e15573
    Abstract: e15573 Background: The role of anti-epidermal growth factor receptor (EGFR) targeting treatment in esophageal squamous cell carcinoma (ESCC) is still uncertain. We conducted a prospective phase 2 study of paclitaxel, cisplatin, and nimotuzumab (TPN) as first-line treatment in unresectable or metastatic ESCC (NCT01336049). The objective response rate was 51.8%. Here we reported long-term follow-up results of that initial trial. Methods: 59 patients were enrolled from Mar 2011 to Apr 2013 and treated with the TPN regimen (nimotuzumab 200mg weekly, paclitaxel 175mg/m 2 on day1, and cisplatin 30mg/m 2 on day1 and 2, repeat every 3 weeks for total six cycles). Patients were allowed to receive sequential radiotherapy in case of local-regional disease or controlling symptom. Results: 56 of 59 patients were eligible for evaluation. After a median follow-up of 32.2months, the median progression-free survival (PFS) and overall survival (OS) were 18.1±4.2 months (95% Confidence: 9.8-26.4) and 26.2±10.0 months (95% Confidence: 6.6-45.8) in 29 patients with unresectable local-regional disease, while those were 6.6±0.4 months (95% Confidence: 5.8-7.5) and 11.5±3.7 months (95% Confidence: 4.2-18.8) respectively in 27 patients with metastatic disease. Patients of male, with multiple lymph node station metastasis, visceral metastasis, no response to TPN treatment, and without radiotherapy had worse OS. Even in some patients with multiple stations lymph node metastasis or recurrent disease of local-regional lymph node metastasis, TPN with sequential radiation seemed could bring longer survival time. But multivariate cox-regression analysis only confirmed that the TPN treatment was associations with OS. Compared with those of complete and partial response, patients of stable disease and progression had poor OS (HR = 2.32, 95% CI: 1.03-5.05, p = 0.03). Conclusions: the combination of nimotuzumab, paclitaxel, and cisplatin is effective as first-line treatment for patients with unresectable and metastatic ESCC, especially those with sequential radiotherapy. Clinical trial information: NCT01336049.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
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  • 5
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 2600-2600
    Abstract: 2600 Background: IMM01, a recombinant SIRPα-Fc fusion protein, can activate macrophages to enhance anti-tumor activity by blocking CD47-SIRPα interaction. Based on preclinical results, IMM01 showed unique property of weak human erythrocyte conjugation. IMM01 plus tislelizumab has the potential to augment both innate and adaptive anti-tumor immune responses. Methods: This study included the phase 1b dose escalation part and the phase 2 dose expansion part. The dose escalation part was conducted with a standard 3+3 design to evaluate the safety, MTD/RP2D and anti-tumor activity in patients with advanced solid tumors. IMM01 (1.0, 1.5, 2.0 mg/kg) was administered once a week and tislelizumab (200mg) was administered once every 3 weeks. The results of the dose escalation part were reported here. Results: As of 26 Dec 2022, 14 pts were enrolled in the dose escalation part, including 5 NSCLC, 2 SCLC, 2 ESCC, 2 CRC, 1 HCC, 1 melanoma and 1 cervical carcinoma. Median age was 61 years (range 49-70). Median of prior therapies was 4 (range 1-10), and 13 pts (92.9%) received previous anti PD-1/L1 treatment. Treatment-related adverse events (TRAEs) occurred in 14 pts (100.0%) to date. Most TRAEs were grade 1-2. The most common TRAEs (≥10%) of all grades were anaemia (85.7%), platelet count decreased (28.6%), asthenia (28.6%), white blood cell count decreased (21.4%), lymphocyte count decreased (21.4%), IRR (21.4%), proteinuria (21.4%), gamma-glutamyltransferase increased (14.3%), white blood cell count increased (14.3%), blood creatine phosphokinase MB increased (14.3%), neutrophil count decreased (14.3%), neutrophil count increased (14.3%), hypoalbuminaemia (14.3%) and hyponatraemia (14.3%). The Grade 3-4 TRAEs were lymphocyte count decreased (21.4%), white blood cell count decreased (14.3%), platelet count decreased (14.3%), blood creatine phosphokinase MB increased (7.1%), blood pressure increased (7.1%) and anaemia (7.1%). No DLT occurred. No TRAE leading to treatment discontinuation was reported. 2 pts (14.3%) had treatment related SAE (2 platelet count decreased), they recovered without platelet transfusion and no bleeding occurred. In 14 pts, 1 pt had confirmed PR and 3 pts had SD. One heavily pre-treated NSCLC pt in the 2.0 mg/kg dose cohort had confirmed PR at Week 12, who was resistant to anti PD-1. One NSCLC pt in 1.5 mg/kg dose cohort and 2 pts (1 SCLC, 1 CRC) in 2.0 mg/kg dose cohort had SD. The treatments of these four pts are ongoing. Conclusions: Up to 2mg/kg IMM01 plus tislelizumab is well tolerated. The RP2D of IMM01 was determined as 2mg/kg, this was the highest IMM01 dose evaluated in human as a single agent. IMM01 plus tislelizumab showed preliminarily anti-tumor activity in patients with advanced solid tumors. The dose expansion part in advanced solid tumors and lymphoma is ongoing. Clinical trial information: chictr20220791 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
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  • 6
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2018
    In:  Journal of Clinical Oncology Vol. 36, No. 4_suppl ( 2018-02-01), p. 133-133
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 4_suppl ( 2018-02-01), p. 133-133
    Abstract: 133 Background: GC is one of the most common cancers worldwide, and has an even higher incidence rate in China. The incidence rate of GC is rising in young pts (≤ 40 years). Previous studies suggested that the percentage of female pts was higher in young pts than that in older pts. The clinical characters and potential prognostic factors have not been well described for young female pts with metastatic GC. Methods: A retrospective chart review was conducted for all GC pts treated at our institution from 1995 to 2012. Pt demographics, clinical characters, treatment related information and survival data were collected. Kaplan-Meier test was used for the survival analysis. Cox regression was conducted for uni- and multi-variate analysis. Results: In total, 1,862 pts with histologically confirmed GC were identified. Among these pts, 11.3% were young pts when first diagnosed. The male to female ratio was 2.76:1 for the whole group and 1:1.02 for young pts. Ninety-eight female pts were ≤ 40 years when diagnosed of metastatic GC. For this group, median age was 35 years (range: 19-40 years). Seventy-one (72.4%) had 〉 1 metastatic sites, and 85 (86.7%) received palliative chemotherapy. The median overall survival (OS) was 14.9 months (95% confidence interval [CI] 11.8-18.0 months). Seventy-six (77.6%) pts had intact primary tumor when diagnosed of metastatic disease. Compared to 22 pts who relapsed after radical surgery, OS was similar for pts presented with de novo metastatic disease (Hazard Ratio (HR) 1.03, 95% CI: 0.55 to 1.92, P= 0.9). Of these 76 pts, 36 underwent palliative gastric resection, which was associated with improved OS (15.3 vs. 9.0 months; HR 0.37, 95% CI: 0.19 to 0.74, P = 0.003). Forty-six (46.9%) pts had ovarian metastasis, and 20 had oophorectomy. Palliative oophorectomy was associated with significantly improved OS (36.6 vs. 12.4 months, HR 0.34, 95% CI: 0.14 to 0.80, P = 0.013). Conclusions: There was an increased ratio of females in young GC pts. In young female pts with metastatic GC, palliative resection of gastric primary and ovarian metastasis were associated with significantly improved OS, and should be considered in appropriate pts.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
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  • 7
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. e21134-e21134
    Abstract: e21134 Background: MET gene amplification is one of the most frequent acquired resistance mechanisms following prior EGFR-TKI monotherapy. HS-10241, an oral and highly selective MET-TKI, may contribute to overcoming common acquired MET-based resistance mechanisms. Here, we reported the preliminary safety and efficacy data of HS-10241 with almonertinib in treatment of advanced NSCLC with EGFR mutation. Methods: This Ph1b study (NCT05430386) was composed of dose escalation part (Part 1) and dose expansion part (Part 2). In Part 1, patients (pts) with EGFR-mutated advanced NSCLC upon disease progression on EGFR-TKI received HS-10241 (BID) plus almonertinib (110 mg QD), and HS-10241 was escalated at 200 mg and 300 mg using a rolling six design. Based on the available data of Part 1, an expansion cohort was opened at HS-10241 300 mg BID with almonertinib 110mg QD to enroll pts with EGFR mutation centrally confirmed and MET-amplification detected by central FISH (MET gene copy number[GCN] ≥5 and/or MET:CEP7 signal ratio ≥2). Results: As of 16 December 2022, 10 pts in part 1, 4 pts at 200 mg and 6 pts at 300 mg HS-10241, and 35 pts in part 2 were enrolled into this study. Of these pts, 13 (28.9%) pts received previous treatment with 1st or 2nd-generation but no 3rd-generation EGFR TKI, 15 (33.3%) pts received 3rd-generation EGFR-TKI only and 15 (33.3%) pts received both 1st/2nd and 3rd-generation EGFR TKIs, whether or not they received treatment with chemotherapy. Only one dose-limiting toxicity (grade 2 Nausea with grade 2 vomiting leading to discontinuation≥14 days) was reported in the cohort with HS-10241 300 mg. The MTD was not reached. Treatment-emergent adverse events (TEAEs) occurred in 41/45 (91.1%) pts. The most common TEAEs (≥ 20%) were increased AST, increased ALT, vomiting, nausea, increased blood creatine phosphokinase, thrombocytopenia, decreased appetite, and increased GGT. Among all the pts, 22 pts with EGFR mutation regardless of the MET gene status were evaluable for efficacy, 12 of which achieved partial response (response rate 54.5%; 8 confirmed PR), and 7 had stable disease (SD). Of the 13 pts who had centrally confirmed EGFR mutation and MET-amplification (6 with GCN ≥10, and 7 with GCN ≥5 but 〈 10), 8 had PR (response rate 61.5%; 5 confirmed PR), and 4 had SD. Among the 8 pts achieving PR, there were 4 with GCN ≥10, and 4 with GCN ≥5 but 〈 10.Moreover, 9 of the 13 pts received both 1st/2nd and 3rd-generation EGFR-TKI and there were 6 PRs (response rate 66.7%;3 confirmed PR) and 2 SDs. Pharmacokinetics analysis showed low risk of potential drug-drug interactions on HS-10241 combined with almonertinib. Conclusions: HS-10241 in combination with almonertinib was well tolerated, and showed encouraging antitumor activity in treatment of advanced NSCLC with EGFR mutation and MET amplification following prior EGFR-TKI, whether MET GCN ≥10 or MET GCN ≥5 but 〈 10. Clinical trial information: NCT05430386 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
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  • 8
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. e15174-e15174
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e15174-e15174
    Abstract: e15174 Background: To evaluate efficacy and toxicity of paclitaxel plus cisplatin in advanced esophageal squamous cell carcinoma (ESCC). Methods: In this single-center, prospective study, chemo-naïve patients with metastastic and recurred ESCC received paclitaxel 175mg/m2 d1 and cisplatin was given on day 1, 2, at a total dose of 75 mg/m 2 over 60 minutes, repeated every 21 days. Efficacy was evaluated every 2 cycles. Results: 133 patients were enrolled between June 2006 and November 2010. The median cycles of chemotherapy accepted were only 3. The objective response rate(RR) of paclitaxel and cisplatin in ESCC patients was 34.2%. After a median follow-up of 24.2 months, the progression free survival (PFS) was limited to 7.0 months (95%CI 5.68-8.32), meanwhile the median overall survival (mOS) was 12.0 months (95%CI 9.93-14.07). In the multivariate Cox regression analysis, distant organ metastasis remained an independent predictor of OS with a hazard ratio of 1.460 (95% CI 0.871-2.446, P = 0.041). 31 patients received radiotherapy after chemotherapy with significantly longer PFS than those without (6.8 months vs. 10 months, p = 0.037), but no difference in OS was observed (12.0 vs. 13.0 months, p = 0.23).Adverse events were tolerable. Conclusions: The efficacy of paclitaxel plus cisplatin in esophageal squamous cell carcinoma is promising. Sequencial chemoradiotherapy could release local progression but no help to overall survival.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
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  • 9
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 4_suppl ( 2022-02-01), p. 453-453
    Abstract: 453 Background: More than 70% of hepatocellular carcinoma (HCC) patients are in the intermediate or advanced stages at the time of diagnosis. TACE, TKI and PD-1 antibody are all recommended for patients with unresectable HCC (uHCC) according to Chinese HCC guidelines. There are few scientific trials to back up the safety and effecacy of TACE+TKI+PD-1 antibody for the treatment of uHCC and conversion resection. In this study, we explored the safety and efficacy of the TACE+TKI+PD-1 antibody in uHCC. Methods: This is a prospective, multicenter, cohort study (NCT04997850). Key Eligibility Criteria:18 years old ≤ age ≤ 70 years old; HCC confirmed by histopathology or cytology; No systemic treatment history. ECOG PS score 0-1; Child-Pugh A/B; BCLC stage B/C.Experience group: TACE + Lenvatinib (12mg when≥ 60kg/8mg when 〈 60kg QD) + Camrelizumab/ Sintilimab (200 mg ivgtt Q3W);Control group: TACE. Results: From Sep 2020 to May 2021, 38 patients were enrolled in experimental group (Table). At the cutoff date (Sep 10 2021), the median follow-up was of 33.34 weeks (Table). The conversion resection rate was 50% (19/38), and the conversion success rate was 52.6% (20/38). Among the 19 patients, 5 cases achieved complete pathological response and 1 case achieved major pathological response. The 48 weeks’ OS rate and PFS were 96.4% (95%CI 92.9% to 99.9%) and 91.7%(95%CI 85.8% to 97.4%).22 patients had level 3 treatment related adverse events (TRAE), there were no level 4 and 5 TRAEs. At the last follow-up, the ORR rate based on mRECIST was 84.2%, and the DCR rate was 94.7% (Table). Conclusions: TACE + Lenvatinib + PD-1 antibody is safe and effective, and conversion resection after the triple-treatment is feasible for uHCC. Clinical trial information: 04997850.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
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  • 10
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 15_suppl ( 2014-05-20), p. e15156-e15156
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
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