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Article: Chemotherapeutic gemcitabine doublets in pancreatic carcinoma.

Richards, Donald A

2005 Volume 32, Issue 4 Suppl 6, Page(s) S9–13

Abstract: Single-agent gemcitabine remains the standard treatment for advanced pancreas cancer. Results of four phase III trials reported in 2004 indicated no survival benefit for single-agent exatecan or combinations of exatecan, pemetrexed, and oxaliplatin with ... ...

Abstract	Single-agent gemcitabine remains the standard treatment for advanced pancreas cancer. Results of four phase III trials reported in 2004 indicated no survival benefit for single-agent exatecan or combinations of exatecan, pemetrexed, and oxaliplatin with gemcitabine compared with gemcitabine alone. It is unclear whether a trend toward improved outcome with the gemcitabine/oxaliplatin combination was attributable to use of a fixed-dose rate infusion regimen of gemcitabine in the combination arm, a method of administration that appears to be associated with benefits compared with standard gemcitabine infusion. Novel approaches to treatment currently under investigation include refining schedules of administration of combination therapy, combining gemcitabine with molecular targeted therapy, and combining gemcitabine with low-molecular-weight heparin.
MeSH term(s)	Antimetabolites, Antineoplastic/administration & dosage ; Antimetabolites, Antineoplastic/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Camptothecin/administration & dosage ; Camptothecin/analogs & derivatives ; Camptothecin/therapeutic use ; Deoxycytidine/administration & dosage ; Deoxycytidine/analogs & derivatives ; Deoxycytidine/therapeutic use ; Humans ; Pancreatic Neoplasms/drug therapy ; Pancreatic Neoplasms/mortality ; Survival Rate
Chemical Substances	Antimetabolites, Antineoplastic ; Deoxycytidine (0W860991D6) ; gemcitabine (B76N6SBZ8R) ; exatecan (OC71PP0F89) ; Camptothecin (XT3Z54Z28A)
Language	English
Publishing date	2005-08
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	189220-4
ISSN	1532-8708 ; 0093-7754
ISSN (online)	1532-8708
ISSN	0093-7754
DOI	10.1053/j.seminoncol.2005.06.024
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Zs.A 1348: Show issues

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Article ; Online: MRTX-500 Phase 2 Trial: Sitravatinib With Nivolumab in Patients With Nonsquamous NSCLC Progressing On or After Checkpoint Inhibitor Therapy or Chemotherapy.

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

2023 Volume 18, Issue 7, Page(s) 907–921

Abstract: Introduction: Sitravatinib, a receptor tyrosine kinase inhibitor targeting TYRO3, AXL, MERTK receptors, and vascular epithelial growth factor receptor 2, can shift the tumor microenvironment toward an immunostimulatory state. Combining sitravatinib with ...

Abstract	Introduction: Sitravatinib, a receptor tyrosine kinase inhibitor targeting TYRO3, AXL, MERTK receptors, and vascular epithelial growth factor receptor 2, can shift the tumor microenvironment toward an immunostimulatory state. Combining sitravatinib with checkpoint inhibitors (CPIs) may augment antitumor activity. Methods: The phase 2 MRTX-500 study evaluated sitravatinib (120 mg daily) with nivolumab (every 2 or 4 wk) in patients with advanced nonsquamous NSCLC who progressed on or after previous CPI (CPI-experienced) or chemotherapy (CPI-naive). CPI-experienced patients had a previous clinical benefit (PCB) (complete response, partial response, or stable disease for at least 12 weeks then disease progression) or no PCB (NPCB) from CPI. The primary end point was objective response rate (ORR); secondary objectives included safety and secondary efficacy end points. Results: Overall, 124 CPI-experienced (NPCB, n = 35; PCB, n = 89) and 32 CPI-naive patients were treated. Investigator-assessed ORR was 11.4% in patients with NPCB, 16.9% with PCB, and 25.0% in CPI-naive. The median progression-free survival was 3.7, 5.6, and 7.1 months with NPCB, PCB, and CPI-naive, respectively; the median overall survival was 7.9 and 13.6 months with NPCB and PCB, respectively (not reached in CPI-naive patients; median follow-up 20.4 mo). Overall, (N = 156), any grade treatment-related adverse events (TRAEs) occurred in 93.6%; grade 3/4 in 58.3%. One grade 5 TRAE occurred in a CPI-naive patient. TRAEs led to treatment discontinuation in 14.1% and dose reduction or interruption in 42.9%. Biomarker analyses supported an immunostimulatory mechanism of action. Conclusions: Sitravatinib with nivolumab had a manageable safety profile. Although ORR was not met, this combination exhibited antitumor activity and encouraged survival in CPI-experienced patients with nonsquamous NSCLC.
MeSH term(s)	Humans ; Nivolumab/pharmacology ; Nivolumab/therapeutic use ; Lung Neoplasms/drug therapy ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/pathology ; Anilides/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Tumor Microenvironment
Chemical Substances	Nivolumab (31YO63LBSN) ; sitravatinib (CWG62Q1VTB) ; Anilides
Language	English
Publishing date	2023-02-24
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article
ZDB-ID	2432037-7
ISSN	1556-1380 ; 1556-0864
ISSN (online)	1556-1380
ISSN	1556-0864
DOI	10.1016/j.jtho.2023.02.016
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Zs.A 6664: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
Zs.MO 652: Show issues

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Article: Myeloprotective Effects of Trilaciclib Among Patients with Small Cell Lung Cancer at Increased Risk of Chemotherapy-Induced Myelosuppression: Pooled Results from Three Phase 2, Randomized, Double-Blind, Placebo-Controlled Studies.

Hussein, Maen / Maglakelidze, Marina / Richards, Donald A / Sabatini, Marielle / Gersten, Todd A / Lerro, Keith / Sinielnikov, Ivan / Spira, Alexander / Pritchett, Yili / Antal, Joyce M / Malik, Rajesh / Beck, J Thaddeus

Cancer management and research

2021 Volume 13, Page(s) 6207–6218

Abstract: Purpose: Trilaciclib is an intravenous cyclin-dependent kinase 4/6 inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression (CIM) by protecting hematopoietic stem and progenitor cells and immune system function from ... ...

Abstract	Purpose: Trilaciclib is an intravenous cyclin-dependent kinase 4/6 inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression (CIM) by protecting hematopoietic stem and progenitor cells and immune system function from chemotherapy-induced damage (myeloprotection). Here, we investigated the myeloprotective effects of trilaciclib among patients at increased risk of CIM. Patients and methods: Data were pooled from three randomized, double-blind, placebo-controlled, phase 2 clinical studies of trilaciclib administered prior to chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC). Myeloprotective outcomes were evaluated in patient subgroups based on age (<65 or ≥65 years), risk of chemotherapy-induced febrile neutropenia (FN), and risk of anemia or red blood cell (RBC) transfusions. For the FN and anemia analyses, risk factors were identified from published literature and used to classify patients into FN and anemia risk categories. Subgroup analysis based on age was also performed on patient reported outcome (PRO) measures. Results: In total, 123 patients received trilaciclib and 119 patients received placebo. Myeloprotective benefits of trilaciclib were observed regardless of age, with greater effects observed among patients aged ≥65 years. Across FN risk factors and categories, trilaciclib had beneficial effects on neutrophil-related endpoints vs placebo, with greater effects observed in patients at higher risk of FN. Effects on RBC-related endpoints favored trilaciclib vs placebo, regardless of anemia risk factors and categories. Improvements in PROs with trilaciclib were observed irrespective of age group, but with greater improvements and less deterioration from baseline observed in older patients. Conclusion: By both decreasing the incidence of CIM and improving quality of life, trilaciclib has the potential to allow patients receiving chemotherapy for ES-SCLC, including patients who are older or more vulnerable to CIM, to receive chemotherapy on schedule and at standard-of-care doses, and to improve the experience for patients receiving chemotherapy to treat ES-SCLC. Clinical trial numbers: NCT02499770; NCT03041311; NCT02514447.
Language	English
Publishing date	2021-08-09
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2508013-1
ISSN	1179-1322
ISSN	1179-1322
DOI	10.2147/CMAR.S313045
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Article ; Online: Randomised phase II trial of gemcitabine and nab-paclitaxel with necuparanib or placebo in untreated metastatic pancreas ductal adenocarcinoma.

O'Reilly, Eileen M / Barone, Diletta / Mahalingam, Devalingam / Bekaii-Saab, Tanios / Shao, Spencer H / Wolf, Julie / Rosano, Molly / Krause, Silva / Richards, Donald A / Yu, Kenneth H / Roach, James M / Flaherty, Keith T / Ryan, David P

European journal of cancer (Oxford, England : 1990)

2020 Volume 132, Page(s) 112–121

Abstract: Background: Necuparanib, a rationally engineered low-molecular-weight heparin, combined with gemcitabine/nab-paclitaxel showed an encouraging safety and oncologic signal in a phase Ib trial. This randomised multicentre phase II trial evaluates the ... ...

Abstract	Background: Necuparanib, a rationally engineered low-molecular-weight heparin, combined with gemcitabine/nab-paclitaxel showed an encouraging safety and oncologic signal in a phase Ib trial. This randomised multicentre phase II trial evaluates the addition of necuparanib or placebo to gemcitabine/nab-paclitaxel in untreated metastatic pancreatic ductal adenocarcinoma (PDAC). Patients and methods: Eligibility included 18 years, histologically or cytologically confirmed metastatic PDAC, measurable disease and Eastern Co-Operative Oncology Group performance status of 0-1. Patients were randomly assigned to necuparanib (5 mg/kg subcutaneous injection once daily) or placebo (subcutaneous injection once daily) and gemcitabine/nab-paclitaxel on days 1, 8 and 15 of 28-day cycles. The primary end-point was median overall survival (OS), and secondary end-points included median progression-free survival, response rates and safety. Results: One-hundred ten patients were randomised, 62 to necuparanib arm and 58 to placebo arm. The futility boundary was crossed at a planned interim analysis, and the study was terminated by the Data Safety Monitoring Board. The median OS was 10.71 months (95% confidence interval [CI]: 7.95-11.96) for necuparanib arm and 9.99 months (95% CI: 7.85-12.85) for placebo arm (hazard ratio: 1.12, 95% CI: 0.66-1.89, P-value: 0.671). The necuparanib arm had a higher incidence of haematologic toxicity relative to placebo patients (83% and 70%). Conclusion: The addition of necuparanib to standard of care treatment for advanced PDAC did not improve OS. Safety was acceptable. No further development of necuparanib is planned although targeting the coagulation cascade pathway remains relevant in PDAC. NCT01621243.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Albumins/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Carcinoma, Pancreatic Ductal/drug therapy ; Carcinoma, Pancreatic Ductal/secondary ; Deoxycytidine/administration & dosage ; Deoxycytidine/analogs & derivatives ; Double-Blind Method ; Female ; Follow-Up Studies ; Heparitin Sulfate/administration & dosage ; Humans ; Male ; Middle Aged ; Paclitaxel/administration & dosage ; Pancreatic Neoplasms/drug therapy ; Pancreatic Neoplasms/pathology ; Prognosis ; Survival Rate
Chemical Substances	130-nm albumin-bound paclitaxel ; Albumins ; Deoxycytidine (0W860991D6) ; Heparitin Sulfate (9050-30-0) ; gemcitabine (B76N6SBZ8R) ; Paclitaxel (P88XT4IS4D)
Language	English
Publishing date	2020-04-28
Publishing country	England
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	82061-1
ISSN	1879-0852 ; 0277-5379 ; 0959-8049 ; 0964-1947
ISSN (online)	1879-0852
ISSN	0277-5379 ; 0959-8049 ; 0964-1947
DOI	10.1016/j.ejca.2020.03.005
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Zs.A 456: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Trilaciclib Prior to Chemotherapy in Patients with Metastatic Triple-Negative Breast Cancer: Final Efficacy and Subgroup Analysis from a Randomized Phase II Study.

Tan, Antoinette R / Wright, Gail S / Thummala, Anu R / Danso, Michael A / Popovic, Lazar / Pluard, Timothy J / Han, Hyo S / Vojnović, Željko / Vasev, Nikola / Ma, Ling / Richards, Donald A / Wilks, Sharon T / Milenković, Dušan / Xiao, Jie / Sorrentino, Jessica / Horton, Janet / O'Shaughnessy, Joyce

Clinical cancer research : an official journal of the American Association for Cancer Research

2021 Volume 28, Issue 4, Page(s) 629–636

Abstract: Purpose: We report final antitumor efficacy results from a phase II study of trilaciclib, an intravenous cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, administered prior to gemcitabine plus carboplatin (GCb) in patients with metastatic triple-negative ...

Abstract	Purpose: We report final antitumor efficacy results from a phase II study of trilaciclib, an intravenous cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, administered prior to gemcitabine plus carboplatin (GCb) in patients with metastatic triple-negative breast cancer (NCT02978716). Patients and methods: Patients were randomized (1:1:1) to group 1 [GCb (days 1, 8); n = 34], group 2 [trilaciclib prior to GCb (days 1, 8); n = 33], or group 3 [trilaciclib (days 1, 8) and trilaciclib prior to GCb (days 2, 9); n = 35]. Subgroup analyses were performed according to CDK4/6 dependence, level of programmed death-ligand 1 (PD-L1) expression, and RNA-based immune signatures using proportional hazards regression. T-cell receptor (TCR) β CDR3 regions were amplified and sequenced to identify, quantify, and compare the abundance of each unique TCRβ CDR3 at baseline and on treatment. Results: Median overall survival (OS) was 12.6 months in group 1, not reached in group 2 (HR = 0.31; P = 0.0016), 17.8 months in group 3 (HR = 0.40; P = 0.0004), and 19.8 months in groups 2 and 3 combined (HR = 0.37; P < 0.0001). Efficacy outcomes were comparable regardless of cancer CDK4/6 dependence status and immune signatures. Administering trilaciclib prior to GCb prolonged OS irrespective of PD-L1 status but had greater benefit in the PD-L1-positive population. T-cell activation was enhanced in patients receiving trilaciclib. Conclusions: Administering trilaciclib prior to GCb enhanced antitumor efficacy, with significant improvements in OS. Efficacy outcomes in immunologic subgroups and enhancements in T-cell activation suggest these improvements may be mediated via immunologic mechanisms.
MeSH term(s)	Antineoplastic Combined Chemotherapy Protocols ; Humans ; Pyrimidines/therapeutic use ; Pyrroles/therapeutic use ; Triple Negative Breast Neoplasms/pathology
Chemical Substances	Pyrimidines ; Pyrroles ; trilaciclib (U6072DO9XG)
Language	English
Publishing date	2021-12-09
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-21-2272
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Article ; Online: A Phase 2 Randomized Placebo-Controlled Adjuvant Trial of GI-4000, a Recombinant Yeast Expressing Mutated RAS Proteins in Patients with Resected Pancreas Cancer.

Muscarella, Peter / Bekaii-Saab, Tanios / McIntyre, Kristi / Rosemurgy, Alexander / Ross, Sharona B / Richards, Donald A / Fisher, William E / Flynn, Patrick J / Mattson, Alicia / Coeshott, Claire / Roder, Heinrich / Roder, Joanna / Harrell, Frank E / Cohn, Allen / Rodell, Timothy C / Apelian, David

Journal of pancreatic cancer

2021 Volume 7, Issue 1, Page(s) 8–19

Abstract: Purpose: ...

Abstract	Purpose:
Language	English
Publishing date	2021-03-23
Publishing country	United States
Document type	Journal Article
ISSN	2475-3246
ISSN (online)	2475-3246
DOI	10.1089/pancan.2020.0021
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Article ; Online: A Phase Ib multicenter, dose-escalation study of the polyamine analogue PG-11047 in combination with gemcitabine, docetaxel, bevacizumab, erlotinib, cisplatin, 5-fluorouracil, or sunitinib in patients with advanced solid tumors or lymphoma.

Murray Stewart, Tracy / Von Hoff, Daniel / Fitzgerald, Michael / Marton, Laurence J / Becerra, Carlos H Roberto / Boyd, Thomas E / Conkling, Paul R / Garbo, Lawrence E / Jotte, Robert M / Richards, Donald A / Smith, David A / Stephenson, Joe J / Vogelzang, Nicholas J / Wu, Hillary H / Casero, Robert A

Cancer chemotherapy and pharmacology

2020 Volume 87, Issue 1, Page(s) 135–144

Abstract: Purpose: Polyamines are absolutely essential for maintaining tumor cell proliferation. PG-11047, a polyamine analogue, is a nonfunctional competitor of the natural polyamine spermine that has demonstrated anticancer activity in cells and animal models ... ...

Abstract	Purpose: Polyamines are absolutely essential for maintaining tumor cell proliferation. PG-11047, a polyamine analogue, is a nonfunctional competitor of the natural polyamine spermine that has demonstrated anticancer activity in cells and animal models of multiple cancer types. Preclinical investigations into the effects of common chemotherapeutic agents have revealed overlap with components of the polyamine metabolic pathway also affected by PG-11047. This report describes a Phase Ib clinical trial investigating PG-11047 in combination with cytotoxic and anti-angiogenic chemotherapeutic agents in patients with advanced refractory metastatic solid tumors or lymphoma. Methods: A total of 172 patients were assigned to treatment arms based on cancer type to receive the appropriate standard-of-care therapy (gemcitabine, docetaxel, bevacizumab, erlotinib, cisplatin, 5-fluorouracil (5-FU), or sunitinib as directed) along with once weekly intravenous infusions of PG-11047. PG-11047 dose escalation ranged from 50 to 590 mg. Results: The maximum tolerated dose (MTD) of PG-11047 in combination with bevacizumab, erlotinib, cisplatin, and 5-FU was 590 mg. Dose-limiting toxicities (DLTs) in these groups were rare (5 of 148 patients). Overall partial responses (PR) were observed in 12% of patients treated with PG-11047 and bevacizumab, with stable disease documented in an additional 40%. Stable disease occurred in 71.4% of patients in the 5-FU arm, 54.1% in the cisplatin arm, and 33.3% in the erlotinib arm. Four of the patients receiving cisplatin + PG-11047 (20%) had unconfirmed PRs. MTDs for gemcitabine, docetaxel, and sunitinib could not be determined due to DLTs at low doses of PG-11047 and small sample size. Conclusions: Results of this Phase Ib trial indicate that PG-11047 can be safely administered to patients in combination with bevacizumab, erlotinib, cisplatin, and 5-FU on the once weekly dosing schedule described and may provide therapeutic benefit. The manageable toxicity profile and high MTD determination provide a safety profile for further clinical studies.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Bevacizumab/administration & dosage ; Cisplatin/administration & dosage ; Deoxycytidine/administration & dosage ; Deoxycytidine/analogs & derivatives ; Docetaxel/administration & dosage ; Dose-Response Relationship, Drug ; Erlotinib Hydrochloride/administration & dosage ; Female ; Fluorouracil/administration & dosage ; Humans ; Lymphoma/drug therapy ; Lymphoma/pathology ; Male ; Maximum Tolerated Dose ; Middle Aged ; Neoplasms/drug therapy ; Neoplasms/pathology ; Spermine/administration & dosage ; Spermine/analogs & derivatives ; Sunitinib/administration & dosage
Chemical Substances	(N(1),N(12))bis(ethyl)-6,7-dehydrospermine ; Deoxycytidine (0W860991D6) ; Docetaxel (15H5577CQD) ; Spermine (2FZ7Y3VOQX) ; Bevacizumab (2S9ZZM9Q9V) ; gemcitabine (B76N6SBZ8R) ; Erlotinib Hydrochloride (DA87705X9K) ; Cisplatin (Q20Q21Q62J) ; Fluorouracil (U3P01618RT) ; Sunitinib (V99T50803M)
Language	English
Publishing date	2020-11-19
Publishing country	Germany
Document type	Clinical Trial, Phase I ; Comparative Study ; Journal Article ; Multicenter Study ; Research Support, N.I.H., Extramural
ZDB-ID	6820-2
ISSN	1432-0843 ; 0344-5704 ; 0943-9404
ISSN (online)	1432-0843
ISSN	0344-5704 ; 0943-9404
DOI	10.1007/s00280-020-04201-1
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Zs.A 1420: Show issues

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Article ; Online: Cancer of the pancreas: are we making progress? A review of studies in the US Oncology Research Network.

Cartwright, Thomas / Richards, Donald A / Boehm, Kristi A

Cancer control : journal of the Moffitt Cancer Center

2008 Volume 15, Issue 4, Page(s) 308–313

Abstract: Background: Pancreatic cancer is the fourth leading cause of cancer deaths in the United States. In 2008, approximately 37,680 people will be diagnosed with pancreatic cancer and 34,290 will die of this disease.: Methods: The authors reviewed the ... ...

Abstract	Background: Pancreatic cancer is the fourth leading cause of cancer deaths in the United States. In 2008, approximately 37,680 people will be diagnosed with pancreatic cancer and 34,290 will die of this disease. Methods: The authors reviewed the literature on treatment of pancreatic cancer with an emphasis on studies conducted in the US Oncology Research (USOR) Network. Results: Although much research has been conducted to develop improved systemic therapies of pancreatic cancer, gemcitabine as a single agent remains the current standard of care. Combinations with other chemotherapeutic drugs or biological agents have resulted in limited improvement. Conclusions: Despite aggressive efforts to improve treatment for patients with pancreatic cancer, limited progress has been made. It is hoped that new studies being planned and conducted will improve outcomes for patients with this disease.
MeSH term(s)	Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Bevacizumab ; Capecitabine ; Cetuximab ; Clinical Trials as Topic ; Deoxycytidine/administration & dosage ; Deoxycytidine/analogs & derivatives ; Deoxycytidine/therapeutic use ; Erlotinib Hydrochloride ; Fluorouracil/administration & dosage ; Fluorouracil/analogs & derivatives ; Humans ; Pancreatic Neoplasms/drug therapy ; Quinazolines/administration & dosage
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Quinazolines ; Deoxycytidine (0W860991D6) ; Bevacizumab (2S9ZZM9Q9V) ; Capecitabine (6804DJ8Z9U) ; gemcitabine (B76N6SBZ8R) ; Erlotinib Hydrochloride (DA87705X9K) ; Cetuximab (PQX0D8J21J) ; Fluorouracil (U3P01618RT)
Language	English
Publishing date	2008-10
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1328503-8
ISSN	1526-2359 ; 1073-2748
ISSN (online)	1526-2359
ISSN	1073-2748
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Article ; Online: Systemic therapy for gastric cancer and adenocarcinoma of the gastroesophageal junction: present status and future directions.

Richards, Donald A / Boehm, Kristi A / Anthony, Stephen P

Expert opinion on investigational drugs

2007 Volume 16, Issue 7, Page(s) 1059–1068

Abstract: Gastric cancer is a major worldwide problem and is a leading cause of death. The incidence of distal gastric cancer is declining; however, there has been a rapid rise in the incidence of adenocarcinoma of the gastroesophageal junction, which is a more ... ...

Abstract	Gastric cancer is a major worldwide problem and is a leading cause of death. The incidence of distal gastric cancer is declining; however, there has been a rapid rise in the incidence of adenocarcinoma of the gastroesophageal junction, which is a more aggressive entity. Combination chemotherapy has significant activity in the treatment of both of these diseases, improving overall survival and quality of life. Despite these improvements, median survival remains at approximately 9 months in patients who are diagnosed at stage IV. This review examines recent advances in the treatment of gastroesophageal junction adenocarcinoma and gastric cancer, newer agents and the potential agents that are in development, which can be logically applied to the treatment of this devastating disease.
MeSH term(s)	Adenocarcinoma/drug therapy ; Adenocarcinoma/mortality ; Adenocarcinoma/pathology ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Clinical Trials, Phase I as Topic ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Drugs, Investigational ; Esophagogastric Junction/pathology ; Female ; Forecasting ; Humans ; Infusions, Intravenous ; Male ; Maximum Tolerated Dose ; Prognosis ; Stomach Neoplasms/drug therapy ; Stomach Neoplasms/mortality ; Stomach Neoplasms/pathology ; Survival Analysis
Chemical Substances	Drugs, Investigational
Language	English
Publishing date	2007-04-27
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1182884-5
ISSN	1744-7658 ; 0967-8298 ; 1354-3784
ISSN (online)	1744-7658
ISSN	0967-8298 ; 1354-3784
DOI	10.1517/13543784.16.7.1059
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Article ; Online: Trilaciclib plus chemotherapy versus chemotherapy alone in patients with metastatic triple-negative breast cancer: a multicentre, randomised, open-label, phase 2 trial.

Tan, Antoinette R / Wright, Gail S / Thummala, Anu R / Danso, Michael A / Popovic, Lazar / Pluard, Timothy J / Han, Hyo S / Vojnović, Željko / Vasev, Nikola / Ma, Ling / Richards, Donald A / Wilks, Sharon T / Milenković, Dušan / Yang, Zhao / Antal, Joyce M / Morris, Shannon R / O'Shaughnessy, Joyce

The Lancet. Oncology

2019 Volume 20, Issue 11, Page(s) 1587–1601

Abstract: Background: Trilaciclib is an intravenous cell-cycle inhibitor that transiently maintains immune cells and haemopoietic stem and progenitor cells in G1 arrest. By protecting the immune cells and bone marrow from chemotherapy-induced damage, trilaciclib ... ...

Abstract	Background: Trilaciclib is an intravenous cell-cycle inhibitor that transiently maintains immune cells and haemopoietic stem and progenitor cells in G1 arrest. By protecting the immune cells and bone marrow from chemotherapy-induced damage, trilaciclib has the potential to optimise antitumour activity while minimising myelotoxicity. We report safety and activity data for trilaciclib plus gemcitabine and carboplatin chemotherapy in patients with metastatic triple-negative breast cancer. Methods: In this randomised, open-label, multicentre, phase 2 study, adult patients (aged ≥18 years) with evaluable, biopsy-confirmed, locally recurrent or metastatic triple-negative breast cancer who had no more than two previous lines of chemotherapy were recruited from 26 sites in the USA, three in Serbia, two in North Macedonia, one in Croatia, and one in Bulgaria; sites were academic and community hospitals. Availability of diagnostic samples of tumour tissue confirming triple-negative breast cancer was a prerequisite for enrolment. Eligible patients were randomly assigned (1:1:1) by an interactive web-response system, stratified by number of previous lines of systemic therapy and the presence of liver metastases, to receive intravenous gemcitabine 1000 mg/m Findings: Between Feb 7, 2017, and May 15, 2018, 142 patients were assessed for eligibility and 102 were randomly assigned to group 1 (n=34), group 2 (n=33), or group 3 (n=35). Of all patients, 38 (37%) had received one or two lines of previous chemotherapy in the metastatic setting. Median follow-up was 8·4 months (IQR 3·8-13·6) for group 1, 12·7 months (5·5-17·4) for group 2, and 12·9 months (6·7-16·8) for group 3. Data cutoff for myelosuppression endpoints was July 30, 2018, and for antitumour activity endpoints was May 17, 2019. During cycle 1, mean duration of severe neutropenia was 0·8 day (SD 2·4) in group 1, 1·5 days (3·5) in group 2, and 1·0 day (2·6) in group 3 (group 3 vs group 1 one-sided adjusted p=0·70). Severe neutropenia occurred in nine (26%) of 34 patients in group 1, 12 (36%) of 33 patients in group 2, and eight (23%) of 35 patients in group 3 (p=0·70). Overall survival was 12·6 months (IQR 5·8-15·6) in group 1, 20·1 months (9·4-not reached) in group 2, and 17·8 months (8·8-not reached) in group 3 (group 3 vs group 1 two-sided p=0·0023). The most common treatment-emergent adverse events were anaemia (22 [73%] of 34), neutropenia (21 [70%]), and thrombocytopenia (18 [60%]) in group 1; neutropenia (27 [82%] of 33), thrombocytopenia (18 [55%]) and anaemia (17 [52%]) in group 2; and neutropenia (23 [66%] of 35), thrombocytopenia (22 [63%]), and nausea (17 [49%]) in group 3. There were no treatment-related deaths. Interpretation: No significant differences were observed in myelosuppression endpoints with trilaciclib plus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer; however, the regimen was generally well tolerated and overall survival results were encouraging. Further studies of trilaciclib in this setting are warranted. Funding: G1 Therapeutics.
MeSH term(s)	Adolescent ; Adult ; Aged ; Antimetabolites, Antineoplastic/administration & dosage ; Antimetabolites, Antineoplastic/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Breast Neoplasms, Male/drug therapy ; Breast Neoplasms, Male/mortality ; Breast Neoplasms, Male/pathology ; Carboplatin/administration & dosage ; Carboplatin/adverse effects ; Deoxycytidine/administration & dosage ; Deoxycytidine/adverse effects ; Deoxycytidine/analogs & derivatives ; Disease Progression ; Europe, Eastern ; Female ; Humans ; Liver Neoplasms/mortality ; Liver Neoplasms/secondary ; Male ; Middle Aged ; Neutropenia/chemically induced ; Progression-Free Survival ; Protein Kinase Inhibitors/administration & dosage ; Protein Kinase Inhibitors/adverse effects ; Pyrimidines/administration & dosage ; Pyrimidines/adverse effects ; Pyrroles/administration & dosage ; Pyrroles/adverse effects ; Risk Factors ; Time Factors ; Triple Negative Breast Neoplasms/drug therapy ; Triple Negative Breast Neoplasms/mortality ; Triple Negative Breast Neoplasms/pathology ; United States ; Young Adult
Chemical Substances	Antimetabolites, Antineoplastic ; Protein Kinase Inhibitors ; Pyrimidines ; Pyrroles ; Deoxycytidine (0W860991D6) ; gemcitabine (B76N6SBZ8R) ; Carboplatin (BG3F62OND5) ; trilaciclib (U6072DO9XG)
Language	English
Publishing date	2019-09-28
Publishing country	England
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2049730-1
ISSN	1474-5488 ; 1470-2045
ISSN (online)	1474-5488
ISSN	1470-2045
DOI	10.1016/S1470-2045(19)30616-3
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