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1.
Hironaga Satake Takeshi Kato Koji Oba Masahito Kotaka Yoshinori Kagawa Hisateru Yasui Masato Nakamura Takanori Watanabe Toshihiko Matsumoto Takayuki Kii Tetsuji Terazawa Akitaka Makiyama Nao Takano Mitsuru Yokota Yoshihiro Okita Koreatsu Matoba Hiroko Hasegawa Akihito Tsuji Yoshito Komatsu Takayuki Yoshino Kentaro Yamazaki Hideyuki Mishima Eiji Oki Naoki Nagata Junichi Sakamoto 《The oncologist》2020,25(12):e13443
Lessons Learned
- A biweekly TAS‐102 plus BEV schedule in patients with heavily pretreated mCRC showed equivalent efficacy with less toxicity compared with the current schedule of TAS‐102 plus BEV combination.
- Biweekly TAS‐102 plus BEV combination could reduce unnecessary dose reduction of TAS‐102, maintain higher doses, and possibly be effective even in cases without chemotherapy‐induced neutropenia (CIN).
- The prespecified subgroup analysis of this study showed an obvious association between CIN within the first two cycles and prognosis of biweekly TAS‐102 plus BEV.
2.
Her-Shyong Shiah Nai-Jung Chiang Chia-Chi Lin Chia-Jui Yen Hui-Jen Tsai Shang-Yin Wu Wu-Chou Su Kwang-Yu Chang Ching-Chiung Wang Jang-Yang Chang Li-Tzong Chen 《The oncologist》2021,26(4):e567-e579
Lessons Learned
- SCB01A is a novel microtubule inhibitor with vascular disrupting activity.
- This first‐in‐human study demonstrated SCB01A safety, pharmacokinetics, and preliminary antitumor activity.
- SCB01A is safe and well tolerated in patients with advanced solid malignancies with manageable neurotoxicity.
3.
Fei Xu Qiufan Zheng Wen Xia Quchang Ouyang Danmei Pang Zhongyu Yuan Yanxia Shi Roujun Peng Qianyi Lu Shusen Wang 《The oncologist》2021,26(5):e742-e748
Lessons Learned
- Fulvestrant 500 mg maintenance therapy showed a clinical benefit rate of 76% and median progression‐free survival of 16.1 months in patients who achieved objective responses or disease control after first‐line chemotherapy.
- Adverse events with fulvestrant maintenance therapy were consistent with the known safety profile of the drug.
4.
Emilie M.J. van Brummelen Sanne Huijberts Carla van Herpen Ingrid Desar Frans Opdam Robin van Geel Serena Marchetti Neeltje Steeghs Kim Monkhorst Bas Thijssen Hilde Rosing Alwin Huitema Jos Beijnen Rene Bernards Jan Schellens 《The oncologist》2021,26(4):290-e545
Lessons Learned
- Afatinib and selumetinib can be combined in continuous and intermittent dosing schedules, albeit at lower doses than approved for monotherapy.
- Maximum tolerated dose for continuous and intermittent schedules is afatinib 20 mg once daily and selumetinib 25 mg b.i.d.
- Because the anticancer activity was limited, further development of this combination is not recommended until better biomarkers for response and resistance are defined.
5.
James J. Harding Robin K. Kelley Benjamin Tan Marinela Capanu Gian Kinh Do Jinru Shia Joanne F. Chou Christine S. Ferrer Chayma Boussayoud Kerri Muenkel Hooman Yarmohammadi Imane El Dika Danny N. Khalil Carmen Ruiz Mariam Rodriguez-Lee Peter Kuhn John Wilton Renuka Iyer Ghassan K. Abou-Alfa 《The oncologist》2020,25(12):e1825-e1836
Lessons Learned
- Androgen receptor as assessed by immunohistochemistry is expressed in a high proportion of patients with hepatocellular carcinoma (HCC).
- Enzalutamide at 160 mg orally daily is safe and tolerable in patients with advanced HCC but has no single‐agent antitumor activity.
- Enzalutamide, a CYP3A4 inducer, at a standard dose of 160 mg reduces the exposure of sorafenib, a CYP3A4 substrate.
- Enzalutamide and sorafenib is safe and tolerable in patients with advanced HCC, but the addition of enzalutamide to sorafenib did not enhance the antitumor activity of sorafenib.
6.
Chun A. Changou Her-Shyong Shiah Li-Tzong Chen Servina Liu Frank Luh Shwu-Huey Liu Yung-Chi Cheng Yun Yen 《The oncologist》2021,26(3):e367-e373
Lessons Learned
- A PHY906 and capecitabine combination could be effective as a salvage therapy for patients with hepatocellular carcinoma (HCC) previously treated with multiple systemic therapies.
- This traditional Chinese medicine formulation can work with Western cancer chemotherapeutic agents to improve clinical outcomes or alleviate side effects for patients with advanced HCC.
7.
ChiaChi Lin TsaiSheng Yang ChiaJui Yen Rebecca Cheng Junjun Liu Chiun Hsu 《The oncologist》2020,25(12)
Lessons Learned
- The combination of ramucirumab (8 mg/kg intravenous, day 1 every 2 weeks) and FOLFOX4 as first‐line treatment in patients with advanced hepatocellular carcinoma (HCC) was not sufficiently tolerated.
- Preliminary efficacy data suggest that the combination may provide clinical benefit to patients with HCC.
- Dose modification and patient selection should be considered for the future development of ramucirumab plus FOLFOX chemotherapy for advanced HCC.
8.
Christian Kollmannsberger Toni K. Choueiri Daniel Y.C. Heng Saby George Fei Jie Ruslan Croitoru Srinivasu Poondru John A. Thompson 《The oncologist》2021,26(3):182-e361
Lessons Learned
- The primary endpoint of this phase II study that evaluated the efficacy and safety of the investigational compound, AGS‐16C3F, versus axitinib in previously treated patients with metastatic renal cell carcinoma (mRCC) was not met.
- Median progression‐free survival, the primary endpoint, was 2.9 months with AGS‐16C3F and 5.7 months with axitinib (HR, 1.676; 95% CI, 1.107–2.537; p = .015), per investigator assessment
- The safety profile for each study drug was as expected, with the most commonly reported adverse events being fatigue (53%) and nausea (47%) in the AGS‐16C3F arm and fatigue (57%) and diarrhea (48%) in the axitinib arm.
- These results provide a benchmark for axitinib use in heavily pretreated patients with mRCC.
9.
Na Zhou Chuantao Zhang Dong Liu Kewei Liu Guanqun Wang Hua Zhu Jianli Zhang Man Jiang Ning Liu Xiaochun Zhang 《The oncologist》2021,26(3):e374-e381
Lessons Learned
- Apatinib combined with S‐1 was not superior to other chemotherapy regimens as first‐line therapy for advanced gastric cancer.
- There was a tendency for patients with lymph node metastasis to have prolonged median progression‐free survival and median overall survival, compared with patients with liver metastasis.
10.
Jennifer E. Amengual Jennifer K. Lue Helen Ma Renee Lichtenstein Bijal Shah Serge Cremers Simon Jones Ahmed Sawas 《The oncologist》2021,26(3):184-e366
Lessons Learned
- Oral selective HDAC6 inhibitors could allow for decreased toxicity compared to pan‐class inhibitors, and increased ease of use.
- ACY‐1215 is well tolerated and led to disease stabilization in 50% of patients treated on a twice‐daily dosing schedule.
- Rational drug combinations with ACY‐1215 improve efficacy in patients with lymphoma.
- Biomarkers such as XBP‐1 level or HDAC6‐score may improve patient selection.
11.
Zhenhuan Zhao Yixue Wen Dongbiao Liao Jidong Miao Yan Gui Hongwei Cai Yang Chen Min Wei Qiang Jia Honggang Tian Mingqiang Sun Yu Zhang Gang Feng Xiaobo Du 《The oncologist》2020,25(12):e13492
Lessons Learned
- The efficacy of single‐agent chemotherapy was not significantly different from that of double‐agent chemotherapy in concurrent chemoradiotherapy for inoperable esophageal squamous cell carcinoma.
- Single‐agent concurrent chemoradiotherapy had lower gastrointestinal and hematologic toxicity.
- Overall survival and progression‐free survival were not significantly different between single‐ and double‐agent concurrent chemoradiotherapy.
12.
Richard Kim Elaine Tan Emily Wang Amit Mahipal Dung-Tsa Chen Biwei Cao Fadzai Masawi Cindy Machado James Yu Dae Won Kim 《The oncologist》2020,25(12):e1893-e1899
Lessons Learned
- The combination of trametinib and sorafenib has an acceptable safety profile, albeit at doses lower than approved for monotherapy.
- Maximum tolerated dose is trametinib 1.5 mg daily and sorafenib 200 mg twice daily.
- The limited anticancer activity observed in this unselected patient population does not support further exploration of trametinib plus sorafenib in patients with hepatocellular carcinoma.
13.
14.
BackgroundIpilimumab is approved for the treatment of advanced melanoma in adults; however, little information on the efficacy and safety of ipilimumab in younger patients is available.MethodsPatients aged 12 to <18 years with previously treated or untreated, unresectable stage III or IV malignant melanoma received ipilimumab 3 or 10 mg/kg every 3 weeks. Primary end-points were 1-year overall survival and safety.ResultsOver a period of 3.5 years, 12 patients received ipilimumab at either 3 mg/kg (n = 4) or 10 mg/kg (n = 8). The median number of ipilimumab doses was four for 3 mg/kg and three for 10 mg/kg. At 1 year, three of four patients on 3 mg/kg and five of eight patients on 10 mg/kg were alive. Two patients on 10 mg/kg had partial response, and one on 3 mg/kg had stable disease. One patient had durable partial response at 3 years without further treatment, at time of this report. There was one grade 3/4 immune-mediated adverse reaction with 3 mg/kg and five with 10 mg/kg. There were no treatment-related deaths. The study was stopped due to slow accrual.ConclusionsAt >1 year follow-up, ipilimumab demonstrated activity in melanoma patients aged 12 to <18 years, with a similar safety profile as that seen in adults. Our trial highlights the difficulties of enrolling younger patients with rare diseases in clinical trials for treatments that are approved in adults, suggesting adolescents with cancer types occurring predominantly in adults should be considered for inclusion in adult trials of promising new drugs.Clinical trial registration: NCT01696045. 相似文献
15.
Perioperative chemotherapy is standard treatment for patients with early high‐risk gastroesophageal adenocarcinoma independent of molecular subtype. Approximately 8% of gastroesophageal cancers have a microsatellite instable phenotype (MSI‐H), and retrospective analyses of neoadjuvant/adjuvant chemotherapy trials suggests no survival benefit in this patient population compared with surgery alone. Patients with advanced MSI‐H malignancies obtain durable responses with immunotherapy using anti–programmed cell death protein 1 (PD‐1) checkpoint blockade. We describe a case of a patient with an early MSI‐H gastroesophageal adenocarcinoma who progressed on neoadjuvant chemotherapy precluding subsequent surgical resection. The patient was subsequently treated with immunotherapy using the anti–PD‐1 antibody nivolumab and the anti–cytotoxic T‐lymphocyte–associated protein 4 (CTLA‐4) antibody ipilimumab leading to a complete remission with biopsies of the residual tumor mass and regional lymph nodes revealing no residual tumor. This case highlights the lack of benefit from neoadjuvant chemotherapy in patients with MSI‐H gastroesophageal cancers and suggests that perioperative anti–PD‐1–based immunotherapy should be further investigated in this patient population.Key Points
- This report describes the successful salvage treatment of a patient with an early high‐risk MSI‐H gastroesophageal carcinoma who progressed through neoadjuvant chemotherapy using combination immunotherapy of the anti–programmed cell death protein 1 (PD‐1) antibody nivolumab and the anti–cytotoxic T‐lymphocyte–associated protein 4 (CTLA‐4) antibody ipilimumab, leading to an ongoing complete remission.
- The case is in keeping with retrospective analyses of perioperative treatment trials demonstrating a lack of chemotherapy benefit in patients with MSI‐H gastroesophageal carcinoma and supports the further investigation of anti–PD‐1–based immunotherapy as a treatment modality in this patient population.
- The case highlights the potential difficulties that may be encountered in the surgical management of patients treated with neoadjuvant immunotherapy with reactive dense fibrotic changes precluding surgical resection.
16.
Margaret E. Gatti-Mays Fatima H. Karzai Sanaz N. Soltani Alexandra Zimmer Jeffrey E. Green Min-Jung Lee Jane B. Trepel Akira Yuno Stanley Lipkowitz Jayakumar Nair Ann McCoy Jung-Min Lee 《The oncologist》2020,25(12):1013-e1824
Lessons Learned
- Monotherapy with prexasertib demonstrated modest activity in BRCA wild‐type, recurrent triple‐negative breast cancer, highlighting the unmet need for combination treatment strategies.
- Neutropenia, anemia, and thrombocytopenia are common with the use of prexasertib but are manageable with supportive care measures. Prophylactic use of granulocyte colony stimulating factor should be considered to avoid dose reductions or treatment delays.
- Pharmacodynamic studies showed prexasertib treatment induced DNA damage in peripheral immune cells.
17.
Ghassan K. Abou-Alfa Robert Mayer Alan P. Venook Allison F. O'Neill Muhammad S. Beg Michael LaQuaglia Peter T. Kingham Rachel Kobos Olca Basturk Cameron Brennan Adam Yopp James J. Harding Stephen Leong John Crown Emir Hoti Gregory Leonard Michele Ly Mikaela Bradley Emily Valentino David Markowitz Alexander Zukiwski Ken Ren John D. Gordan 《The oncologist》2020,25(12):e1837-e1845
18.
Li Chu Yun Chen Qi Liu Fei Liang Shengping Wang Quan Liu Hui Yu Xianghua Wu Junhua Zhang Jiaying Deng Dashan Ai Zhengfei Zhu Yongzhan Nie Kuaile Zhao 《The oncologist》2021,26(6):e925-e935
Lessons Learned
- Apatinib has potential as an effective and safe second‐line or higher treatment for patients with chemotherapy‐refractory esophageal squamous cell carcinoma (ESCC).
- Clinical safety is of potential concern when administering apatinib to patients with uncontrolled esophageal lesions or severe invasion of trachea, bronchi, or major blood vessels.
- To the best of the authors'' knowledge, this is the first prospective phase II study to investigate apatinib for patients with chemotherapy‐refractory ESCC. Apatinib could provide an alternative option for ESCC after first‐line or higher therapy in carefully selected patients.
19.
《Annals of oncology》2013,24(11):2911-2915
BackgroundPatients with advanced uveal melanoma have a poor prognosis and limited treatment options. Ipilimumab is approved for pre-treated adult patients with advanced melanoma. However, because previous clinical trials with ipilimumab have excluded patients with uveal melanoma, data in this patient population are limited.Patients and methodsPre-treated patients with advanced uveal melanoma received ipilimumab 3 mg/kg through an expanded access programme, every 3 weeks for four doses. Tumour assessments were conducted at baseline and after completion of treatment and patients were monitored throughout for adverse events.ResultsAmong 82 assessable patients, 4 (5%) had an immune-related objective response and 24 (29%) had immune-related stable disease lasting ≥3 months for an immune-related disease control rate of 34%. With a median follow-up of 5.6 months, median overall survival (OS) was 6.0 months and median progression-free survival (PFS) was 3.6 months. The 1-year rates of OS and PFS were 31% and 11%, respectively. The safety profile of ipilimumab was similar to that in patients with cutaneous melanoma.ConclusionsThese data suggest ipilimumab 3 mg/kg is a feasible option in pre-treated patients with metastatic uveal melanoma. Evidence of disease control and a 1-year survival rate of 31% indicate the need for further investigation in randomised, controlled trials to determine the optimal timing and use of ipilimumab in this patient population. 相似文献
20.
Thomas J. George Alison M. Ivey Azka Ali Ji-Hyun Lee Yu Wang Karen C. Daily Brian H. Ramnaraign Sanda A. Tan Krista P. Terracina Thomas E. Read Long H. Dang Atif Iqbal 《The oncologist》2021,26(5):362-e724
Lessons Learned
- Treatment for patients with metastatic colorectal cancer (mCRC) typically involves multiple lines of therapy with eventual development of treatment resistance.
- In this single‐arm, phase II study involving heavily pretreated patients, the combination of sorafenib and capecitabine yielded a clinically meaningful progression‐free survival of 6.2 months with an acceptable toxicity profile.
- This oral doublet therapy is worthy of continued investigation for clinical use in patients with mCRC.