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Efficacy and safety of anlotinib plus penpulimab as second-line treatment for small cell lung cancer:A multicenter,open-label,single-arm phase ii trial

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Cancer Pathogenesis and Therapy 2024年第4期2卷 268-275页

作者： Changgong Zhang Jianhua Chen Huijuan Wu Jun Wang Liying Gao Jun Zhao Yan Sun Zhongyao Jia Xinlin Mu Chunmei Bai Rui Wang Kailiang Wu Qiang Liu Yuankai Shi Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing 100021China Department I of Thoracic Oncology Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of MedicineCentral South UniversityChangshaHunan 410083China Department of Oncology The Affiliated Cancer Hospital of Zhengzhou UniversityZhengzhouHenan 450000China Department ii of Head and Neck Tumor Gansu Provincial Cancer HospitalLanzhouGansu 730050China Department iiI of Radiotherapy Gansu Provincial Cancer HospitalLanzhouGansu 730050China Department I of Thoracic Oncology Beijing Cancer HospitalBeijing 100142China Department of Oncology Linyi People's HospitalLinyiShandong 276002China Department of Respiratory and Critical Care Medicine Peking University People's HospitalBeijing 100032China Department of Medical Oncology Peking Union Medical College HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100730China Department of Thoracic Surgery The Fourth Hospital of Hebei Medical UniversityShijiazhuangHebei 050000China Department of Radiation Oncology Shanghai Proton and Heavy Ion CenterFudan University Cancer HospitalShanghai 200030China Department I of Oncology Shenyang Chest HospitalShenyangLiaoning 110044China

Background:Currently,the need for new therapeutic strategies involving programmed cell death protein-1(PD-1)monoclonal antibodies in the second-line setting of small cell lung cancer(SCLC)is *** study aimed to evaluate the efficacy and safety of anlotinib plus penpulimab as a second-line treatment for patients with SCLC who progressed after first-line platinum-based ***:This study included the patients from Cohort 4 of a single-arm,open-label,multicenter,phase ii clinical trial.A safety run-in phase was performed under anlotinib(10/12 mg quaque die[QD],days 1–14)plus penpulimab(200 mg intravenously[IV],day 1)in a 21-day cycle,followed by the formal trial in which the patients received anlotinib(12 mg QD,days 1–14)plus penpulimab(200 mg IV,day 1)in a 21-day *** primary endpoint of the safety run-in phase was *** primary endpoint of the formal trial phase was the objective response rate(ORR).Results:From April 28,2020,to November 24,2020,21 patients were enrolled from 11 hospitals,including 2 in the safety run-in phase and 19 in the formal trial *** the formal trial phase,the ORR was 42.1%(8/19;95%confidence interval[CI]:17.7–66.6%).The median progression-free survival was 4.8 months(95%CI:2.9–11.3 months),and the median overall survival was 13.0 months(95%CI:4.6–not applicable[NA]months).The incidence of grade 3 treatment-related adverse events(TRAEs)was 52.4%(11/21),and the incidence of treatment-related serious adverse events(AEs)was 28.6%(6/21).Two AE-related deaths *** most common AEs were hypertension(57.1%,12/21),hypothyroidism(42.9%,9/21),and hypertriglyceridemia(38.1%,8/21).Conclusions:In patients with SCLC who progressed after first-line platinum-based chemotherapy,the second-line anlotinib plus penpulimab treatment demonstrates promising anti-cancer activity and a manageable safety profile,which warrants further investigation.

关键词： Anlotinib Penpulimab Small cell lung cancer Efficacy Safety phase ii trial

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CapOX as neoadjuvant chemotherapy for locally advanced operable colon cancer patients: a prospective single-arm phase Ⅱ trial

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Chinese Journal of Cancer Research 2016年第6期28卷 589-597页

作者： Fangqi Liu Li Yang Yuchen Wu Cong Li Jiang Zhao Adili Keranmu Hongtu Zheng Dan Huang Lei Wang Tong Tong Junyan Xu Ji Zhu Sanjun Cai Ye Xu Department of Colorectal Surgery Fudan University Shanghai Cancer Center Department of Oncology Shanghai Medical College Fudan University Department of Pathology Fudan University Shanghai Cancer Center Department of Radiology Fudan University Shanghai Cancer Center Department of Nuclear Medicine Fudan University Shanghai Cancer Center Department of Radiation Oncology Fudan University Shanghai Cancer Center Clinical Statistics Center Fudan University Shanghai Cancer Center

Objective： The aim of this prospective, single-arm phase ii trial was to confirm the safety and efficacy of neoadjuvant chemotherapy（NAC） using oxaliplatin plus capecitabine（Cap OX） for patients with operable locally advanced colon cancer（CC）.Methods： Patients with computed tomography-defined T4 or lymph node-positive CCs were enrolled. After radiological staging, patients were treated with at least 2 cycles of NAC consisting of 130 mg/m2 oxaliplatin on d 1,plus 1,000 mg/m2 capecitabine twice daily for 14 d every 3 weeks, followed by surgery, and then with the rest cycles of adjuvant chemotherapy. Radiological response was evaluated after 2 cycles of NAC. Tumor response, treatment toxicity, and surgical complications were recorded. The pathological response to therapy was evaluated according to the tumor regression grade（TRG） score. The primary endpoint was pathologic tumor response. This trial is registered in Clinical ***（No： NCT02415829）.Results： Forty-seven patients were enrolled in the study. Forty-two patients completed the planned *** total radiological response rate was 68%（32/47）, including complete and partial response rates of 2%（1/47）and 66%（31/47）, respectively. Stable disease was observed in 32%（15/47） and progressive disease was observed in none. Complete pathologic response, major regression, and at least moderate regression were achieved in 1（2%）, 2（4%）, and 29（62%） patients, respectively. Four patients developed grade 3 treatment toxicities. One patient with wound infection occurred after operation（1/47, 2%）. There was no treatment-related ***： Our results suggest that NAC with Cap OX is an effective and safe treatment option for patients with locally advanced CCs.

关键词： Colon cancer neoadjuvant chemotherapy phase ii trial surgery

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First-line erlotinib and fixed dose-rate gemcitabine for advanced pancreatic cancer

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World Journal of Gastroenterology 2013年第28期19卷 4511-4519页

作者： Vanja Vaccaro Emilio Bria Isabella Sperduti Alain Gelibter Luca Moscetti Giovanni Mansueto Enzo Maria Ruggeri Teresa Gamucci Francesco Cognetti Michele Milella Department of Medical Oncology Regina Elena National Cancer Institute 00144 Rome Italy Medical Oncology Azienda Ospedaliera Universitaria Integrata 37134 Verona Italy Department of Biostatistics and Scientific Direction Regina Elena National Cancer Institute 00144 Rome Italy Medical Oncology Ospedale "Belcolle" 01100 Viterbo Italy S.S. Trinità Hospital Sora 03039 Frosinone Italy Department of Medical Oncology Regina Elena National Cancer Institute 00144 Rome Italy

AIM: To investigate activity, toxicity, and prognostic factors for survival of erlotinib and fixed dose-rate gemcitabine (FDR-Gem) in advanced pancreatic cancer.METHODS: We designed a single-arm prospective, multicentre, open-label phase ii study to evaluate the combination of erlotinib (100 mg/d, orally) and weekly FDR-Gem (1000 mg/m2, infused at 10 mg/m2 per minute) in a population of previously untreated patients with locally advanced, inoperable, or metastatic pancreatic cancer. Primary endpoint was the rate of progression-free survival at 6 mo (PFS-6); secondary endpoints were overall response rate (ORR), response duration, tolerability, overall survival (OS), and clinical benefit. Treatment was not considered to be of further interest if the PFS-6 was 40% would be of considerable interest (p1 = 40%); with a 5% rejection error (α = 5%) and a power of 80%, 35 fully evaluable patients with metastatic disease were required to be enrolled in order to complete the study. Analysis of prognostic factors for survival was also carried out.RESULTS: From May 2007 to September 2009, 46 patients were enrolled (male/female: 25/21; median age: 64 years; median baseline carbohydrate antigen 19-9 (CA 19-9): 897 U/mL; locally advanced/metastatic disease: 5/41). PFS-6 and median PFS were 30.4% and 14 wk (95%CI: 10-19), respectively; 1-year and median OS were 20.2% and 26 wk (95%CI: 8-43). Five patients achieved an objective response (ORR: 10.9%, 95%CI: 1.9-19.9); disease control rate was 56.5% (95%CI: 42.2-70.8); clinical benefit rate was 43.5% (95%CI: 29.1-57.8). CA 19-9 serum levels were decreased by > 25% as compared to baseline in 14/23 evaluable patients (63.6%). Treatment was well-tolerated, with skin rash being the most powerful predictor of both longer PFS (P < 0.0001) and OS (P = 0.01) at multivariate analysis (median OS for patients with or without rash: 42 wk vs 15 wk, respectively, Log-rank P = 0.03). Additional predictors of bett

关键词： Pancreatic cancer Gemcitabine Fixed dose-rate Erlotinib Prognostic factors Cutaneous rash phase ii trial

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Neoadjuvant therapy for resectable pancreatic cancer

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World Journal of Gastrointestinal Oncology 2017年第12期9卷 457-465页

作者： Sheikh Hasibur Rahman Robin Urquhart Michele Molinari Department of Surgery Dalhousie University Department of Surgery University of Pittsburgh Medical Center

The use of neoadjuvant therapies has played a major role for borderline resectable and locally advanced pancreatic cancers(PCs). For this group of patients, preoperative chemotherapy or chemoradiation has increased the likelihood of surgery with negative resection margins and overall survival. On the other hand, for patients with resectable PC, the main rationale for neoadjuvant therapy is that the overall survival with current strategies is unsatisfactory. There is a consensus that we need new treatments to improve the overall survival and quality of life of patients with PC. However, without strong scientific evidence supporting the theoretical advantages of neoadjuvant therapies, these potential benefits might turn out not to be worth the risk of tumors progression while waiting for surgery. The focus of this paper is to provide the readers an overview of the most recent evidence on this subject.

关键词： Pancreatic adenocarcinoma Neoadjuvant chemotherapy Neoadjuvant chemoradiation therapy Meta-analysis Decision analysis Borderline resectable Locally advanced Randomized controlled trial phase I trial phase ii trial phase iiI trial

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