Martin J Edelman1, Mary W Redman2, Kathy S Albain3, Eric C McGary4, Noman M Rafique5, Daniel Petro6, Saiama N Waqar7, Katherine Minichiello2, Jieling Miao2, Vassiliki A Papadimitrakopoulou8, Karen Kelly9, David R Gandara9, Roy S Herbst10. 1. Fox Chase Cancer Center, Philadelphia, Pennsylvania. Electronic address: Martin.edelman@fccc.edu. 2. SWOG Statistics and Data Management Center at Fred Hutchinson Cancer Reseach Center, Seattle, Washington. 3. Loyola University Chicago Stritch School of Medicine, Maywood, Illinois. 4. Kaiser Permanente National Community Oncology Research Program/Kaiser Permanente Medical Group, Los Angeles, California. 5. Mercy Medical Center Tri-County Hematology/Oncology Association, Canton, Ohio. 6. University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania. 7. Washington University School of Medicine, St. Louis, Missouri. 8. Thoracic/Head and Neck Medical Oncology, University of Texas M. D. Anderson Cancer Center, Houston, Texas. 9. University of California Davis Cancer Center, Sacramento, California. 10. Medical Oncology, Yale Cancer Center, New Haven, Connecticut.
Abstract
OBJECTIVE: Lung-MAP (SWOG S1400) is a master platform trial assessing targeted therapies in squamous NSCLC. The objective of study C (S1400C) was to evaluate the response rate to palbociclib, a cyclin-dependent kinase 4 and cyclin-dependent kinase 6 inhibitor, in patients with cell cycle gene abnormalities. METHODS: Patients with squamous NSCLC, a performance status of 0 to 2, and normal organ function who had progressed after at least one prior platinum-based chemotherapy with cyclin-dependent kinase 4 gene (CDK4) or cyclin D1 gene (CCND1), cyclin D2 gene (CCND2), or cyclin D3 gene (CCND3) amplifications on tumor specimens were eligible. The study was originally designed as a phase II/III trial comparing palbociclib with docetaxel, but it was modified to a single-arm phase II trial with the primary end point of response when immunotherapy was approved. If two or fewer responses were seen in the first 20 patients, then the study would cease enrollment. RESULTS: A total of 88 patients (9% of patients screened) were assigned to S1400C, and 53 patients enrolled (including 17 to receive docetaxel). One patient who had been registered to receive docetaxel was re-registered to receive palbociclib after progression while taking docetaxel. The frequencies of cell cycle gene alterations in the eligible patients taking palbociclib (n = 32) were as follows: CCND1, 81% (n = 26); CCND2, 9% (n = 3); CCND3, 6% (n = 2); and CDK4, 3% (n = 1). In all, 32 eligible patients received palbociclib. There were two partial responses (response rate 6% [95% confidence interval (CI): 0%-15%]), both with CCND1 amplification. Twelve patients had stable disease (38% [95% CI: 21%-54%]). The median progression-free survival was 1.7 months (95% CI: 1.6-2.9 months) and the median overall survival was 7.1 months (95% CI: 4.2-12.5). CONCLUSION: Palbociclib as monotherapy failed to demonstrate the prespecified criteria for advancement to phase III testing.
OBJECTIVE: Lung-MAP (SWOG S1400) is a master platform trial assessing targeted therapies in squamous NSCLC. The objective of study C (S1400C) was to evaluate the response rate to palbociclib, a cyclin-dependent kinase 4 and cyclin-dependent kinase 6 inhibitor, in patients with cell cycle gene abnormalities. METHODS:Patients with squamous NSCLC, a performance status of 0 to 2, and normal organ function who had progressed after at least one prior platinum-based chemotherapy with cyclin-dependent kinase 4 gene (CDK4) or cyclin D1 gene (CCND1), cyclin D2 gene (CCND2), or cyclin D3 gene (CCND3) amplifications on tumor specimens were eligible. The study was originally designed as a phase II/III trial comparing palbociclib with docetaxel, but it was modified to a single-arm phase II trial with the primary end point of response when immunotherapy was approved. If two or fewer responses were seen in the first 20 patients, then the study would cease enrollment. RESULTS: A total of 88 patients (9% of patients screened) were assigned to S1400C, and 53 patients enrolled (including 17 to receive docetaxel). One patient who had been registered to receive docetaxel was re-registered to receive palbociclib after progression while taking docetaxel. The frequencies of cell cycle gene alterations in the eligible patients taking palbociclib (n = 32) were as follows: CCND1, 81% (n = 26); CCND2, 9% (n = 3); CCND3, 6% (n = 2); and CDK4, 3% (n = 1). In all, 32 eligible patients received palbociclib. There were two partial responses (response rate 6% [95% confidence interval (CI): 0%-15%]), both with CCND1 amplification. Twelve patients had stable disease (38% [95% CI: 21%-54%]). The median progression-free survival was 1.7 months (95% CI: 1.6-2.9 months) and the median overall survival was 7.1 months (95% CI: 4.2-12.5). CONCLUSION:Palbociclib as monotherapy failed to demonstrate the prespecified criteria for advancement to phase III testing.
Authors: Roy S Herbst; David R Gandara; Fred R Hirsch; Mary W Redman; Michael LeBlanc; Philip C Mack; Lawrence H Schwartz; Everett Vokes; Suresh S Ramalingam; Jeffrey D Bradley; Dana Sparks; Yang Zhou; Crystal Miwa; Vincent A Miller; Roman Yelensky; Yali Li; Jeff D Allen; Ellen V Sigal; David Wholley; Caroline C Sigman; Gideon M Blumenthal; Shakun Malik; Gary J Kelloff; Jeffrey S Abrams; Charles D Blanke; Vassiliki A Papadimitrakopoulou Journal: Clin Cancer Res Date: 2015-02-13 Impact factor: 12.531
Authors: Julie Brahmer; Karen L Reckamp; Paul Baas; Lucio Crinò; Wilfried E E Eberhardt; Elena Poddubskaya; Scott Antonia; Adam Pluzanski; Everett E Vokes; Esther Holgado; David Waterhouse; Neal Ready; Justin Gainor; Osvaldo Arén Frontera; Libor Havel; Martin Steins; Marina C Garassino; Joachim G Aerts; Manuel Domine; Luis Paz-Ares; Martin Reck; Christine Baudelet; Christopher T Harbison; Brian Lestini; David R Spigel Journal: N Engl J Med Date: 2015-05-31 Impact factor: 91.245
Authors: Angela DeMichele; Amy S Clark; Kay See Tan; Daniel F Heitjan; Kristi Gramlich; Maryann Gallagher; Priti Lal; Michael Feldman; Paul Zhang; Christopher Colameco; David Lewis; Melissa Langer; Noah Goodman; Susan Domchek; Keerthi Gogineni; Mark Rosen; Kevin Fox; Peter O'Dwyer Journal: Clin Cancer Res Date: 2014-12-11 Impact factor: 12.531
Authors: Keith T Flaherty; Patricia M Lorusso; Angela Demichele; Vandana G Abramson; Rachel Courtney; Sophia S Randolph; M Naveed Shaik; Keith D Wilner; Peter J O'Dwyer; Gary K Schwartz Journal: Clin Cancer Res Date: 2011-11-16 Impact factor: 12.531
Authors: Hossein Borghaei; Luis Paz-Ares; Leora Horn; David R Spigel; Martin Steins; Neal E Ready; Laura Q Chow; Everett E Vokes; Enriqueta Felip; Esther Holgado; Fabrice Barlesi; Martin Kohlhäufl; Oscar Arrieta; Marco Angelo Burgio; Jérôme Fayette; Hervé Lena; Elena Poddubskaya; David E Gerber; Scott N Gettinger; Charles M Rudin; Naiyer Rizvi; Lucio Crinò; George R Blumenschein; Scott J Antonia; Cécile Dorange; Christopher T Harbison; Friedrich Graf Finckenstein; Julie R Brahmer Journal: N Engl J Med Date: 2015-09-27 Impact factor: 91.245
Authors: Garrett M Frampton; Alex Fichtenholtz; Geoff A Otto; Kai Wang; Sean R Downing; Jie He; Michael Schnall-Levin; Jared White; Eric M Sanford; Peter An; James Sun; Frank Juhn; Kristina Brennan; Kiel Iwanik; Ashley Maillet; Jamie Buell; Emily White; Mandy Zhao; Sohail Balasubramanian; Selmira Terzic; Tina Richards; Vera Banning; Lazaro Garcia; Kristen Mahoney; Zac Zwirko; Amy Donahue; Himisha Beltran; Juan Miguel Mosquera; Mark A Rubin; Snjezana Dogan; Cyrus V Hedvat; Michael F Berger; Lajos Pusztai; Matthias Lechner; Chris Boshoff; Mirna Jarosz; Christine Vietz; Alex Parker; Vincent A Miller; Jeffrey S Ross; John Curran; Maureen T Cronin; Philip J Stephens; Doron Lipson; Roman Yelensky Journal: Nat Biotechnol Date: 2013-10-20 Impact factor: 54.908
Authors: G K Schwartz; P M LoRusso; M A Dickson; S S Randolph; M N Shaik; K D Wilner; R Courtney; P J O'Dwyer Journal: Br J Cancer Date: 2011-05-24 Impact factor: 7.640
Authors: Philip Bland; Ioanna Mavrommati; Gareth Muirhead; Barrie Peck; Hannah Cottom; Patty T Wai; Sarah L Maguire; Holly E Barker; Eamonn Morrison; Divya Kriplani; Lu Yu; Amy Gibson; Giulia Falgari; Keith Brennan; Gillian Farnie; Richard Buus; Rebecca Marlow; Daniela Novo; Eleanor Knight; Naomi Guppy; Daniela Kolarevic; Snezana Susnjar; Natasa Medic Milijic; Kalnisha Naidoo; Patrycja Gazinska; Ioannis Roxanis; Sunil Pancholi; Lesley-Ann Martin; Erle M Holgersen; Maggie C U Cheang; Farzana Noor; Sophie Postel-Vinay; Gerard Quinn; Simon McDade; Lukas Krasny; Paul Huang; Frances Daley; Fredrik Wallberg; Jyoti S Choudhary; Syed Haider; Andrew N Tutt; Rachael Natrajan Journal: Cancer Res Date: 2021-01-28 Impact factor: 12.701
Authors: Jordan L Kohlmeyer; David J Gordon; Munir R Tanas; Varun Monga; Rebecca D Dodd; Dawn E Quelle Journal: Int J Mol Sci Date: 2020-04-24 Impact factor: 5.923
Authors: Mary W Redman; Vassiliki A Papadimitrakopoulou; Katherine Minichiello; Fred R Hirsch; Philip C Mack; Lawrence H Schwartz; Everett Vokes; Suresh Ramalingam; Natasha Leighl; Jeff Bradley; Jieling Miao; James Moon; Louise Highleyman; Crystal Miwa; Michael L LeBlanc; Shakun Malik; Vincent A Miller; Ellen V Sigal; Stacey Adam; David Wholley; Caroline Sigman; Beverly Smolich; Charles D Blanke; Karen Kelly; David R Gandara; Roy S Herbst Journal: Lancet Oncol Date: 2020-10-27 Impact factor: 41.316
Authors: Shankha Satpathy; Karsten Krug; Pierre M Jean Beltran; Sara R Savage; Francesca Petralia; Chandan Kumar-Sinha; Yongchao Dou; Boris Reva; M Harry Kane; Shayan C Avanessian; Suhas V Vasaikar; Azra Krek; Jonathan T Lei; Eric J Jaehnig; Tatiana Omelchenko; Yifat Geffen; Erik J Bergstrom; Vasileios Stathias; Karen E Christianson; David I Heiman; Marcin P Cieslik; Song Cao; Xiaoyu Song; Jiayi Ji; Wenke Liu; Kai Li; Bo Wen; Yize Li; Zeynep H Gümüş; Myvizhi Esai Selvan; Rama Soundararajan; Tanvi H Visal; Maria G Raso; Edwin Roger Parra; Özgün Babur; Pankaj Vats; Shankara Anand; Tobias Schraink; MacIntosh Cornwell; Fernanda Martins Rodrigues; Houxiang Zhu; Chia-Kuei Mo; Yuping Zhang; Felipe da Veiga Leprevost; Chen Huang; Arul M Chinnaiyan; Matthew A Wyczalkowski; Gilbert S Omenn; Chelsea J Newton; Stephan Schurer; Kelly V Ruggles; David Fenyö; Scott D Jewell; Mathangi Thiagarajan; Mehdi Mesri; Henry Rodriguez; Sendurai A Mani; Namrata D Udeshi; Gad Getz; James Suh; Qing Kay Li; Galen Hostetter; Paul K Paik; Saravana M Dhanasekaran; Ramaswamy Govindan; Li Ding; Ana I Robles; Karl R Clauser; Alexey I Nesvizhskii; Pei Wang; Steven A Carr; Bing Zhang; D R Mani; Michael A Gillette Journal: Cell Date: 2021-08-05 Impact factor: 66.850