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1. Intracranial Efficacy of Selpercatinib in RET Fusion-Positive Non–Small Cell Lung Cancers on the LIBRETTO-001 TrialIntracranial Efficacy of Selpercatinib in RET Fusion+ NSCLC

Author

Subbiah, Vivek, Gainor, Justin F, Oxnard, Geoffrey R, Tan, Daniel SW, Owen, Dwight H, Cho, Byoung Chul, Loong, Herbert H, McCoach, Caroline E, Weiss, Jared, Kim, Yu Jung, Bazhenova, Lyudmila, Park, Keunchil, Daga, Haruko, Besse, Benjamin, Gautschi, Oliver, Rolfo, Christian, Zhu, Edward Y, Kherani, Jennifer F, Huang, Xin, Kang, Suhyun, and Drilon, Alexander

Subjects
Lung Cancer, Brain Disorders, Cancer, Clinical Trials and Supportive Activities, Lung, Clinical Research, Neurosciences, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Proto-Oncogene Proteins c-ret, Pyrazoles, Pyridines, Treatment Outcome, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeWe report the intracranial efficacy of selpercatinib, a highly potent and selective RET inhibitor, approved in the United States for RET fusion-positive non-small cell lung cancers (NSCLC).Patients and methodsIn the global phase 1/2 LIBRETTO-001 trial (NCT03157128) in advanced RET-altered solid tumors, selpercatinib was dosed orally (160 mg twice every day) in 28-day cycles. Patients with baseline intracranial metastases had MRI/CT scans every 8 weeks for 1 year (12 weeks thereafter). In this pre-planned analysis of patients with RET fusion-positive NSCLC with baseline intracranial metastases, the primary endpoint was independently assessed intracranial objective response rate (ORR) per RECIST 1.1. Secondary endpoints included intracranial disease control rate, intracranial duration of response, and intracranial progression-free survival (PFS) independently reviewed.ResultsEighty patients with NSCLC had brain metastases at baseline. Patients were heavily pretreated (median = 2 systemic therapies, range = 0-10); 56% of patients received ≥1 course of intracranial radiation (14% whole brain radiotherapy, 45% stereotactic radiosurgery). Among 22 patients with measurable intracranial disease at baseline, intracranial ORR was 82% [95% confidence interval (CI), 60-95], including 23% with complete responses. Among all intracranial responders (measurable and nonmeasurable, n = 38), median duration of intracranial response was not reached (95% CI, 9.3-NE) at a median duration of follow-up of 9.5 months (IQR = 5.7, 12.0). At 12 months, 55% of intracranial responses were ongoing. In all 80 patients, median intracranial PFS was 13.7 months (95% CI, 10.9-NE) at a median duration of follow-up of 11.0 months (IQR = 7.4, 16.5). No new safety signals were revealed in patients with brain metastases compared with the full NSCLC trial population.ConclusionsSelpercatinib has robust and durable intracranial efficacy in patients with RET fusion-positive NSCLC.

Published
2021

2. Efficacy of Selpercatinib in RET-Altered Thyroid Cancers.

Author

Wirth, Lori, Sherman, Eric, Robinson, Bruce, Solomon, Benjamin, Kang, Hyunseok, Lorch, Jochen, Worden, Francis, Brose, Marcia, Patel, Jyoti, Leboulleux, Sophie, Godbert, Yann, Barlesi, Fabrice, Morris, John, Owonikoko, Taofeek, Tan, Daniel, Gautschi, Oliver, Weiss, Jared, de la Fouchardière, Christelle, Burkard, Mark, Laskin, Janessa, Taylor, Matthew, Kroiss, Matthias, Medioni, Jacques, Goldman, Jonathan, Bauer, Todd, Levy, Benjamin, Zhu, Viola, Lakhani, Nehal, Moreno, Victor, Ebata, Kevin, Nguyen, Michele, Heirich, Dana, Zhu, Edward, Huang, Xin, Yang, Luxi, Kherani, Jennifer, Rothenberg, S, Drilon, Alexander, Subbiah, Vivek, Shah, Manisha, and Cabanillas, Maria

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Female, Humans, Hypertension, Intention to Treat Analysis, Kaplan-Meier Estimate, Male, Middle Aged, Mutation, Progression-Free Survival, Protein Kinase Inhibitors, Proto-Oncogene Proteins c-ret, Pyrazoles, Pyridines, Thyroid Neoplasms, Transaminases, Treatment Outcome, Young Adult
Abstract

BACKGROUND: RET mutations occur in 70% of medullary thyroid cancers, and RET fusions occur rarely in other thyroid cancers. In patients with RET-altered thyroid cancers, the efficacy and safety of selective RET inhibition are unknown. METHODS: We enrolled patients with RET-mutant medullary thyroid cancer with or without previous vandetanib or cabozantinib treatment, as well as those with previously treated RET fusion-positive thyroid cancer, in a phase 1-2 trial of selpercatinib. The primary end point was an objective response (a complete or partial response), as determined by an independent review committee. Secondary end points included the duration of response, progression-free survival, and safety. RESULTS: In the first 55 consecutively enrolled patients with RET-mutant medullary thyroid cancer who had previously received vandetanib, cabozantinib, or both, the percentage who had a response was 69% (95% confidence interval [CI], 55 to 81), and 1-year progression-free survival was 82% (95% CI, 69 to 90). In 88 patients with RET-mutant medullary thyroid cancer who had not previously received vandetanib or cabozantinib, the percentage who had a response was 73% (95% CI, 62 to 82), and 1-year progression-free survival was 92% (95% CI, 82 to 97). In 19 patients with previously treated RET fusion-positive thyroid cancer, the percentage who had a response was 79% (95% CI, 54 to 94), and 1-year progression-free survival was 64% (95% CI, 37 to 82). The most common adverse events of grade 3 or higher were hypertension (in 21% of the patients), increased alanine aminotransferase level (in 11%), increased aspartate aminotransferase level (in 9%), hyponatremia (in 8%), and diarrhea (in 6%). Of all 531 patients treated, 12 (2%) discontinued selpercatinib owing to drug-related adverse events. CONCLUSIONS: In this phase 1-2 trial, selpercatinib showed durable efficacy with mainly low-grade toxic effects in patients with medullary thyroid cancer with and without previous vandetanib or cabozantinib treatment. (Funded by Loxo Oncology and others; LIBRETTO-001 ClinicalTrials.gov number, NCT03157128.).

Published
2020

3. Efficacy of Selpercatinib in RET Fusion–Positive Non–Small-Cell Lung Cancer

Author

Drilon, Alexander, Oxnard, Geoffrey R, Tan, Daniel SW, Loong, Herbert HF, Johnson, Melissa, Gainor, Justin, McCoach, Caroline E, Gautschi, Oliver, Besse, Benjamin, Cho, Byoung C, Peled, Nir, Weiss, Jared, Kim, Yu-Jung, Ohe, Yuichiro, Nishio, Makoto, Park, Keunchil, Patel, Jyoti, Seto, Takashi, Sakamoto, Tomohiro, Rosen, Ezra, Shah, Manisha H, Barlesi, Fabrice, Cassier, Philippe A, Bazhenova, Lyudmila, De Braud, Filippo, Garralda, Elena, Velcheti, Vamsidhar, Satouchi, Miyako, Ohashi, Kadoaki, Pennell, Nathan A, Reckamp, Karen L, Dy, Grace K, Wolf, Jürgen, Solomon, Benjamin, Falchook, Gerald, Ebata, Kevin, Nguyen, Michele, Nair, Binoj, Zhu, Edward Y, Yang, Luxi, Huang, Xin, Olek, Elizabeth, Rothenberg, S Michael, Goto, Koichi, and Subbiah, Vivek

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Cancer, Lung, Clinical Research, Lung Cancer, Adult, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung, Female, Humans, Hypertension, Intention to Treat Analysis, Lung Neoplasms, Male, Middle Aged, Mutation, Progression-Free Survival, Protein Kinase Inhibitors, Proto-Oncogene Proteins c-ret, Pyrazoles, Pyridines, Transaminases, Treatment Outcome, Young Adult, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundRET fusions are oncogenic drivers in 1 to 2% of non-small-cell lung cancers (NSCLCs). In patients with RET fusion-positive NSCLC, the efficacy and safety of selective RET inhibition are unknown.MethodsWe enrolled patients with advanced RET fusion-positive NSCLC who had previously received platinum-based chemotherapy and those who were previously untreated separately in a phase 1-2 trial of selpercatinib. The primary end point was an objective response (a complete or partial response) as determined by an independent review committee. Secondary end points included the duration of response, progression-free survival, and safety.ResultsIn the first 105 consecutively enrolled patients with RET fusion-positive NSCLC who had previously received at least platinum-based chemotherapy, the percentage with an objective response was 64% (95% confidence interval [CI], 54 to 73). The median duration of response was 17.5 months (95% CI, 12.0 to could not be evaluated), and 63% of the responses were ongoing at a median follow-up of 12.1 months. Among 39 previously untreated patients, the percentage with an objective response was 85% (95% CI, 70 to 94), and 90% of the responses were ongoing at 6 months. Among 11 patients with measurable central nervous system metastasis at enrollment, the percentage with an objective intracranial response was 91% (95% CI, 59 to 100). The most common adverse events of grade 3 or higher were hypertension (in 14% of the patients), an increased alanine aminotransferase level (in 12%), an increased aspartate aminotransferase level (in 10%), hyponatremia (in 6%), and lymphopenia (in 6%). A total of 12 of 531 patients (2%) discontinued selpercatinib because of a drug-related adverse event.ConclusionsSelpercatinib had durable efficacy, including intracranial activity, with mainly low-grade toxic effects in patients with RET fusion-positive NSCLC who had previously received platinum-based chemotherapy and those who were previously untreated. (Funded by Loxo Oncology and others; LIBRETTO-001 ClinicalTrials.gov number, NCT03157128.).

Published
2020

4. IASLC Lung Cancer Staging Project: The New Database to Inform Revisions in the Ninth Edition of the TNM Classification of Lung Cancer

Author

Asamura, Hisao, Rusch, Valerie, Rami-Porta, Ramón, Araujo, Luiz Henrique, Beer, David, Bertoglio, Pietro, Beyruti, Ricardo, Billè, Andrea, Boubia, Souheil, Brambilla, Elisabeth, Cangir, A.K., Carbone, David, Cilento, Vanessa, Connolly, Casey, Darling, Gail, Detterbeck, Frank, Dibaba, Daniel, D’Journo, Xavier Benoit, Donington, Jessica, Eberhardt, Wilfried, Edwards, John, Erasmus, Jeremy, Fang, Wentao, Fennell, Dean, Fong, Kwun, Galateau-Sallé, Françoise, Gautschi, Oliver, Gill, Ritu R., Giroux, Dorothy, Giuliani, Meredith, Goo, Jin Mo, Hasegawa, Seiki, Hirsch, Fred, Hoffman, Hans, Hofstetter, Wayne, Huang, James, Joubert, Philippe, Kernstine, Kemp, Kerr, Keith, Kim, Young Tae, Kim, Dong Kwan, Kindler, Hedy, Lievens, Yolande, Liu, Hui, Low, Donald E., Lyons, Gustavo, MacMahon, Heber, Mahar, Alyson, Marino, Mirella, Marom, Edith M., Matilla, José-María, van Meerbeeck, Jan, Montuenga, Luis M., Nicholson, Andrew, Nishimura, Katie, Nowak, Anna, Opitz, Isabelle, Okumura, Meinoshin, Osarogiagbon, Raymond U., Pass, Harvey, de Perrot, Marc, Prosch, Helmut, Rice, David, Rimner, Andreas, Rosenthal, Adam, Ruffini, Enrico, Sakai, Shuji, Van Schil, Paul, Singh, Navneet, Suárez, Francisco, Terra, Ricardo M., Travis, William D., Tsao, Ming S., Ugalde, Paula, Watanabe, Shun-ichi, Wistuba, Ignacio, Wynes, Murry, Yatabe, Yasushi, Nishimura, Katherine K., Giroux, Dorothy J., Chansky, Kari, and Hoering, Antje

Published
2023
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5. Somatic rearrangements causing oncogenic ectodomain deletions of FGFR1 in squamous cell lung cancer

Author

Malchers, Florian, Nogova, Lucia, van Attekum, Martijn H.A., Maas, Lukas, Bragelmann, Johannes, Bartenhagen, Christoph, Girard, Luc, Bosco, Graziella, Dahmen, Ilona, Michels, Sebastian, Weeden, Clare E., Scheel, Andreas H., Meder, Lydia, Golfmann, Kristina, Schuldt, Philipp, Siemanowski, Janna, Rehker, Jan, Merkelbach-Bruse, Sabine, Menon, Roopika, Gautschi, Oliver, Heuckmann, Johannes M., Brambilla, Elisabeth, Asselin-Labat, Marie-Liesse, Persigehl, Thorsten, Minna, John D., Walczak, Henning, Ullrich, Roland T., Fischer, Matthias, Reinhardt, Hans Christian, Wolf, Jurgen, Buttner, Reinhard, Peifer, Martin, George, Julie, and Thomas, Roman K.

Subjects
Thermo Fisher Scientific Inc., Pazopanib -- Health aspects, Lung cancer -- Genetic aspects -- Care and treatment, Health care industry
Abstract

The discovery of frequent 8p11-p12 amplifications in squamous cell lung cancer (SQLC) has fueled hopes that FGFR1, located inside this amplicon, might be a therapeutic target. In a clinical trial, only 11% of patients with 8p11 amplification (detected by FISH) responded to FGFR kinase inhibitor treatment. To understand the mechanism of FGFR1 dependency, we performed deep genomic characterization of 52 SQLCs with 8p11-p12 amplification, including 10 tumors obtained from patients who had been treated with FGFR inhibitors. We discovered somatically altered variants of FGFR1 with deletion of exons 1-8 that resulted from intragenic tail-to-tail rearrangements. These ectodomain-deficient FGFR1 variants ([DELTA]EC-FGFR1) were expressed in the affected tumors and were tumorigenic in both in vitro and in vivo models of lung cancer. Mechanistically, breakage-fusion-bridges were the source of 8p11-p12 amplification, resulting from frequent head-to-head and tail-to-tail rearrangements. Generally, tail-to-tail rearrangements within or in close proximity upstream of FGFR1 were associated with FGFR1 dependency. Thus, the genomic events shaping the architecture of the 8p11-p12 amplicon provide a mechanistic explanation for the emergence of FGFR1-driven SQLC. Specifically, we believe that FGFR1 ectodomain-deficient and FGFRI-centered amplifications caused by tail-to-tail rearrangements are a novel somatic genomic event that might be predictive of therapeutically relevant FGFR1 dependency., Introduction Squamous cell lung cancer (SQLC) is the second most common lung cancer subtype and among the cancers with the worst prognosis (1). Unfortunately, genetically activated kinase targets that provide [...]

Published
2023
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6. Exploratory analysis of front-line therapies in REVEL: a randomised phase 3 study of ramucirumab plus docetaxel versus docetaxel for the treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy.

Author

Garon, Edward B, Scagliotti, Giorgio Vittorio, Gautschi, Oliver, Reck, Martin, Thomas, Michael, Iglesias Docampo, Lara, Kalofonos, Haralabos, Kim, Joo-Hang, Gans, Steven, Brustugun, Odd Terje, Orlov, Sergey V, Cuyun Carter, Gebra, Zimmermann, Annamaria H, Oton, Ana B, Alexandris, Ekaterine, Lee, Pablo, Wolff, Katharina, Stefaniak, Victoria Jennifer, Socinski, Mark A, and Pérol, Maurice

Subjects
Humans, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Disease Progression, Platinum, Antineoplastic Combined Chemotherapy Protocols, Neoplasm Staging, Female, Antibodies, Monoclonal, Humanized, Docetaxel, chemotherapy, metastatic, non-squamous, squamous, vascular endothelial growth factor receptor, Lung, Clinical Research, Clinical Trials and Supportive Activities, Lung Cancer, Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions
Abstract

Non-small-cell lung cancer (NSCLC) is a heterogeneous disease. Front-line therapy may affect responses to subsequent treatment regimens, thus influencing second-line therapy decision making. In the randomised phase 3 REVEL study, second-line ramucirumab plus docetaxel (ram+doc) versus docetaxel (doc) improved survival of patients with metastatic NSCLC. We explore efficacy, safety and quality-of-life (QoL) in REVEL based on front-line therapy. Patients were grouped by specific front-line therapy received. Overall survival (OS), progression-free survival (PFS), objective response rate, safety and QoL were assessed descriptively. Kaplan-Meier estimation and Cox proportional hazards modelling were used; frequencies reported in percentages. Baseline characteristics of 1253 patients were generally well balanced between treatment arms within each front-line therapy subgroup. For patients with non-squamous disease (n=912), induction therapies included platinum-based chemotherapy plus a taxane (n=227; 25%) or pemetrexed (n=449; 49%), with (n=172; 19%) or without bevacizumab. For patients with squamous disease (n=328), induction therapies included platinum-based chemotherapy plus gemcitabine (n=176; 54%) or a taxane (n=69; 21%). A highly selected subgroup (n=127; 14%) received pemetrexed continuation maintenance therapy. Ram+doc improved median OS and PFS versus doc across front-line therapy subgroups, as reflected by HRs ranging from 0.78 to 0.91 and 0.66 to 0.92, respectively, similar to results in the overall intention-to-treat cohort (HRs: 0.86 and 0.76, respectively). High-grade treatment-emergent adverse events of special interest (including neutropenia, febrile neutropenia, leucopenia and hypertension) were generally higher in ram+doc-treated patients relative to doc-treated patients regardless of front-line therapy. No clear differences in safety or QoL were seen across front-line therapy subgroups; outcomes were consistent with those reported in the overall intention-to-treat cohort. Results of this exploratory analysis suggest that second-line ram+doc may be effective regardless of prior treatment with platinum-based chemotherapy plus a taxane, pemetrexed, gemcitabine or bevacizumab. Overall, ram+doc is clinically beneficial across a wide range of patients with metastatic NSCLC who have progressed after various front-line therapies. NCT01168973.

Published
2020

8. Drugging the catalytically inactive state of RET kinase in RET-rearranged tumors

Author

Plenker, Dennis, Riedel, Maximilian, Brägelmann, Johannes, Dammert, Marcel A, Chauhan, Rakhee, Knowles, Phillip P, Lorenz, Carina, Keul, Marina, Bührmann, Mike, Pagel, Oliver, Tischler, Verena, Scheel, Andreas H, Schütte, Daniel, Song, Yanrui, Stark, Justina, Mrugalla, Florian, Alber, Yannic, Richters, André, Engel, Julian, Leenders, Frauke, Heuckmann, Johannes M, Wolf, Jürgen, Diebold, Joachim, Pall, Georg, Peifer, Martin, Aerts, Maarten, Gevaert, Kris, Zahedi, René P, Buettner, Reinhard, Shokat, Kevan M, McDonald, Neil Q, Kast, Stefan M, Gautschi, Oliver, Thomas, Roman K, and Sos, Martin L

Subjects
Orphan Drug, Rare Diseases, Cancer, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Good Health and Well Being, Adenocarcinoma, Adenocarcinoma of Lung, Animals, Cell Line, Tumor, Cytoskeletal Proteins, Drug Resistance, Neoplasm, Gene Rearrangement, Heterocyclic Compounds, 4 or More Rings, Humans, Imidazoles, Lung Neoplasms, Mice, Mutation, NIH 3T3 Cells, Protein Kinase Inhibitors, Proto-Oncogene Proteins c-ret, Pyridazines, Biological Sciences, Medical and Health Sciences
Abstract

Oncogenic fusion events have been identified in a broad range of tumors. Among them, RET rearrangements represent distinct and potentially druggable targets that are recurrently found in lung adenocarcinomas. We provide further evidence that current anti-RET drugs may not be potent enough to induce durable responses in such tumors. We report that potent inhibitors, such as AD80 or ponatinib, that stably bind in the DFG-out conformation of RET may overcome these limitations and selectively kill RET-rearranged tumors. Using chemical genomics in conjunction with phosphoproteomic analyses in RET-rearranged cells, we identify the CCDC6-RETI788N mutation and drug-induced mitogen-activated protein kinase pathway reactivation as possible mechanisms by which tumors may escape the activity of RET inhibitors. Our data provide mechanistic insight into the druggability of RET kinase fusions that may be of help for the development of effective therapies targeting such tumors.

Published
2017

9. A Randomized Open-Label Phase III Trial Evaluating the Addition of Denosumab to Standard First-Line Treatment in Advanced NSCLC: The European Thoracic Oncology Platform (ETOP) and European Organisation for Research and Treatment of Cancer (EORTC) SPLENDOUR Trial

Author

Peters, Solange, Danson, Sarah, Hasan, Baktiar, Dafni, Urania, Reinmuth, Niels, Majem, Margarita, Tournoy, Kurt G., Mark, Michael T., Pless, Miklos, Cobo, Manuel, Rodriguez-Abreu, Delvys, Falchero, Lionel, Moran, Teresa, Ortega Granados, Ana Laura, Monnet, Isabelle, Mohorcic, Katja, Sureda, Bartomeu Massutí, Betticher, Daniel, Demedts, Ingel, Macias, Jose Antionio, Cuffe, Sinead, Luciani, Andrea, Sanchez, Jose Garcia, Curioni-Fontecedro, Alessandra, Gautschi, Oliver, Price, Gillian, Coate, Linda, von Moos, Roger, Zielinski, Christoph, Provencio, Mariano, Menis, Jessica, Ruepp, Barbara, Pochesci, Alessia, Roschitzki-Voser, Heidi, Besse, Benjamin, Rabaglio, Manuela, O’Brien, Mary E.R., and Stahel, Rolf A.

Published
2020
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10. RET Solvent Front Mutations Mediate Acquired Resistance to Selective RET Inhibition in RET-Driven Malignancies

Author

Solomon, Benjamin J., Tan, Lavinia, Lin, Jessica J., Wong, Stephen Q., Hollizeck, Sebastian, Ebata, Kevin, Tuch, Brian B., Yoda, Satoshi, Gainor, Justin F., Sequist, Lecia V., Oxnard, Geoffrey R., Gautschi, Oliver, Drilon, Alexander, Subbiah, Vivek, Khoo, Christine, Zhu, Edward Y., Nguyen, Michele, Henry, Dahlia, Condroski, Kevin R., Kolakowski, Gabrielle R., Gomez, Eliana, Ballard, Joshua, Metcalf, Andrew T., Blake, James F., Dawson, Sarah-Jane, Blosser, Wayne, Stancato, Louis F., Brandhuber, Barbara J., Andrews, Steve, Robinson, Bruce G., and Rothenberg, S. Michael

Published
2020
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11. The IASLC Lung Cancer Staging Project: Analysis of Resection Margin Status and Proposals for Residual Tumor Descriptors for Non–Small Cell Lung Cancer

Author

Asamura, Hisao, Rusch, Valerie, Rami-Porta, Ramón, Araujo, Luiz Henrique, Beer, David, Bertoglio, Pietro, Beyruti, Ricardo, Bille, Andrea, Bolejack, Vanessa, Boubia, Souheil, Brambilla, Elisabeth, Brierley, James D., Cangir, A.K., Carbone, David, Chansky, Kari, Crowley, John, Darling, Gail, Detterbeck, Frank, D’Journo, Xavier Benoit, Donnington, Jessica, Eberhardt, Wilfried, Edwards, John, Erasmus, Jeremy, Falkson, Conrad, Fang, Wentao, Fennell, Dean, Fong, Kwun, Galateau-Salle, Françoise, Gautschi, Oliver, Gill, Ritu, Giroux, Dorothy, Giuliani, Meredith, Goo, Jin Mo, Hasegawa, Seiki, Hirsch, Fred, Hoffman, Hans, Hofstetter, Wayne, Huang, James, Joubert, Philippe, Kernstine, Kemp, Kerr, Keith, Kim, Young Tae, Kim, Hong Kwan, Kindler, Hedy, Lievens, Yolande, Liu, Hui, Low, Donald E., Lyons, Gustavo, MacMahon, Heber, Marino, Mirella, Marom, Edith, Matilla, José-María, van Meerbeeck, Jan, Montuenga, Luis M., Nicholson, Andrew, Nishimura, Katie, Nowak, Anna, Opitz, Isabelle, Okumura, Meinoshin, Osarogiagbon, Raymond U., Pass, Harvey, de Perrot, Marc, Prosch, Helmut, Rice, David, Rimner, Andreas, Ruffini, Enrico, Sakai, Shuji, Van Schil, Paul, Singh, Navneet, Stoll-D’Astice, Amy, Su´rez, Francisco, Terra, Ricardo M., Travis, William D., Tsao, Ming S., Ugalde, Paula, Waller, David, Watanabe, Shun-ichi, Wiens, Jacinta, Wistuba, Ignacio, Yatabe, Yasushi, Jiang, Liyan, Kubota, Kaoru, Turna, Akif, Weksler, Benny, Tzukazan, Maria Teresa, Tammemägi, Martin, Powell, Charles, Naidich, David, Liu, Hongxu, Armato, Samuel, Brunelli, Alex, Cardillo, Giuseppe, David, Elizabeth, Fournier, Brigitte, Krasnik, Mark, Kubota, Kauro, Labbe, Catherine, Lim, Eric, Putora, Paul Martin, Rocco, Gaetano, Filosso, Pier Luigi, Kondo, Kazuya, Kim, Dong Kwan, Giaccone, Giuseppe, Lucchi, Marco, Infante, Maurizio, Rice, Thomas, Ferguson, Mark, Adsusmilli, Prasad, Travis, William, Suárez, Francisco, Kubota, Kaura, Shun-ichi, Watanabe, Hisao Asamura, Nicholson, Andrew G., Ramón, Rami-Porta, Edith Marom, Tsao, Ming, Shun-ichi, Watanabe, Ming Tsao, Guiliani, Meredith, Brierley, James, Terra, Ricardo, Osarogiagbon, Ray, Montuenga, Luis, Wang, Hongwei, Nakajima, Jun, Galateau, Françoise, Ostrowski, Marcin, Goo, Jim Mo, Travis, Bill, Matilla, Jose Maria, St. Pierre, Carolle, Tzukazan, Ma Teresa, Girard, Nicholas, Rimmer, Andreas, Galateau, Francoise, Adusumilli, Prasad, D’Journo, Xavier, Low, Donald, Rosenthal, Adam, Edwards, John G., Donington, Jessica, Galateau-Sallé, Françoise, Hoffmann, Hans, Marom, Edith M., Tsao, Ming-Sound, Giroux, Dorothy J., Shemanski, Lynn, and Krasnik, Marc

Published
2020
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12. Evolution and Clinical Impact of EGFR Mutations in Circulating Free DNA in the BELIEF Trial

Author

Molina-Vila, Miguel-Angel, Stahel, Rolf A., Dafni, Urania, Jordana-Ariza, Núria, Balada-Bel, Ariadna, Garzón-Ibáñez, Mónica, García-Peláez, Beatriz, Mayo-de-las-Casas, Clara, Felip, Enriqueta, Curioni Fontecedro, Alessandra, Gautschi, Oliver, Peters, Solange, Massutí, Bartomeu, Palmero, Ramon, Ponce Aix, Santiago, Carcereny, Enric, Früh, Martin, Pless, Miklos, Popat, Sanjay, Cuffe, Sinead, Bidoli, Paolo, Kammler, Roswitha, Roschitzki-Voser, Heidi, Tsourti, Zoi, Karachaliou, Niki, and Rosell, Rafael

Published
2020
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15. Clonal dynamics of BRAF-driven drug resistance in EGFR-mutant lung cancer

Author

Schaufler, Diana, Ast, David F., Tumbrink, Hannah L., Abedpour, Nima, Maas, Lukas, Schwäbe, Ayla E., Spille, Inga, Lennartz, Stefanie, Fassunke, Jana, Aldea, Mihaela, Besse, Benjamin, Planchard, David, Nogova, Lucia, Michels, Sebastian, Kobe, Carsten, Persigehl, Thorsten, Westphal, Theresa, Koleczko, Sophia, Fischer, Rieke, Weber, Jan-Phillip, Altmüller, Janine, Thomas, Roman K., Merkelbach-Bruse, Sabine, Gautschi, Oliver, Mezquita, Laura, Büttner, Reinhard, Wolf, Jürgen, Peifer, Martin, Brägelmann, Johannes, Scheffler, Matthias, and Sos, Martin L.

Published
2021
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16. Multimodal Treatment in Operable Stage III NSCLC: A Pooled Analysis on Long-Term Results of Three SAKK trials (SAKK 16/96, 16/00, and 16/01)

Author

Früh, Martin, Betticher, Daniel C., Stupp, Roger, Xyrafas, Alexandros, Peters, Solange, Ris, Hans Beat, Mirimanoff, Rene Olivier, Ochsenbein, Adrian F., Schmid, Ralph, Matzinger, Oscar, Stahel, Rolf A., Weder, Walter, Guckenberger, Matthias, Rothschild, Sacha I., Lardinois, Didier, Mach, Nicholas, Mark, Michael, Gautschi, Oliver, Thierstein, Sandra, Biaggi Rudolf, Christine, and Pless, Miklos

Published
2019
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19. The IASLC Lung Cancer Staging Project: A Renewed Call to Participation

Author

Asamura, Hisao, Rusch, Valerie, Rami-Porta, Ramón, Araujo, Luiz Henrique, Beckett, Paul, Beer, David, Bertoglio, Pietro, Beyruti, Ricardo, Bille, Andrea, Bolejack, Vanessa, Boubia, Souheil, Brambilla, Elisabeth, Brierley, James D., Cangir, A.K., Carbone, David, Chansky, Kari, Crowley, John, Darling, Gail, Detterbeck, Frank, D’Journo, Xavier Benoit, Donnington, Jessica, Eberhardt, Wilfried, Edwards, John, Erasmus, Jeremy, Fang, Wentao, Fennell, Dean, Fong, Kwun, Galateau-Salle, Françoise, Gautschi, Oliver, Gill, Ritu, Giroux, Dorothy, Goo, Jin Mo, Hasegawa, Seiki, Hirsch, Fred, Hoffman, Hans, Hofstetter, Wayne, Huang, James, Joubert, Philippe, Kernstine, Kemp, Kerr, Keith, Kim, Young Tae, Kim, Hong Kwan, Kindler, Hedy, Lievens, Yolande, Liu, Hui, Low, Donald E., Lyons, Gustavo, MacMahon, Heber, Marino, Mirella, Marom, Edith, Matilla, José-María, van Meerbeeck, Jan, Montuenga, Luis M., Nicholson, Andrew, Nowak, Anna, Opitz, Isabelle, Okumura, Meinoshin, Osarogiagbon, Raymond U., Pass, Harvey, de Perrot, Marc, Prosch, Helmut, Rice, David, Rimner, Andreas, Ruffini, Enrico, Sakai, Shuji, Van Schil, Paul, Singh, Navneet, Stoll-D’Astice, Amy, Suárez, Francisco, Terra, Ricardo M., Travis, William D., Tsao, Ming S., Ugalde, Paula, Watanabe, Shun-ichi, Wiens, Jacinta, Wistuba, Ignacio, Yatabe, Yasushi, Jiang, Liyan, Kubota, Kaoru, Lim, Eric, Putora, Paul Martin, Turna, Akif, Filosso, Pier Luigi, Kondo, Kazuya, Kim, Dong Kwan, Giaccone, Giuseppe, Lucchi, Marco, Blackwell, Eugene, Rice, Thomas, Travis, William, Nicholson, Andrew G., Tsao, Ming, Brierley, James, Nakajima, Jun, Galateau, Françoise, Travis, Bill, Goo, Jim Mo, Montuenga, Luis, Wang, Hong Wei, Nishimura, Katie, Giroux, Dorothy J., Crowley, John J., and Rusch, Valerie W.

Published
2018
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21. Early Clearance of Plasma Epidermal Growth Factor Receptor Mutations as a Predictor of Outcome on Osimertinib in Advanced Non–Small Cell Lung Cancer; Exploratory Analysis from AURA3 and FLAURA

Author

Gray, Jhanelle E., primary, Ahn, Myung-Ju, additional, Oxnard, Geoffrey R., additional, Shepherd, Frances A., additional, Imamura, Fumio, additional, Cheng, Ying, additional, Okamoto, Isamu, additional, Cho, Byoung Chul, additional, Lin, Meng-Chih, additional, Wu, Yi-Long, additional, Majem, Margarita, additional, Gautschi, Oliver, additional, Boyer, Michael, additional, Bulusu, Krishna C., additional, Markovets, Aleksandra, additional, Barrett, J. Carl, additional, Hodge, Rachel, additional, McKeown, Astrid, additional, Hartmaier, Ryan J., additional, Chmielecki, Juliann, additional, Papadimitrakopoulou, Vassiliki A., additional, and Ramalingam, Suresh S., additional

Published
2023
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24. «Less is more» bei medikamentösen Tumortherapien

Author

Hecz, Magdalena, primary, Aebi, Stefan, additional, Mller, Beat, additional, Zander, Thilo, additional, Riklin, Christian, additional, Winterhalder, Ralph, additional, Weiler, Daniela, additional, Zeidler, Kristin, additional, Blum, Veronika, additional, Niederberger, Philipp, additional, Campana, Benedetta, additional, and Gautschi, Oliver, additional

Published
2023
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25. «Less is more» pour les traitements médicamenteux des cancers

Author

Hecz, Magdalena, primary, Aebi, Stefan, additional, Mller, Beat, additional, Zander, Thilo, additional, Riklin, Christian, additional, Winterhalder, Ralph, additional, Weiler, Daniela, additional, Zeidler, Kristin, additional, Blum, Veronika, additional, Niederberger, Philipp, additional, Campana, Benedetta, additional, and Gautschi, Oliver, additional

Published
2023
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26. Targeted Therapy for Patients with BRAF-Mutant Lung Cancer Results from the European EURAF Cohort

Author

Gautschi, Oliver, Milia, Julie, Cabarrou, Bastien, Bluthgen, Marie-Virginia, Besse, Benjamin, Smit, Egbert F, Wolf, Juergen, Peters, Solange, Früh, Martin, Koeberle, Dieter, Oulkhouir, Youssouf, Schuler, Martin, Curioni-Fontecedro, Alessandra, Huret, Benjamin, Kerjouan, Mallorie, Michels, Sebastian, Pall, Georg, Rothschild, Sacha, Schmid-Bindert, Gerald, Scheffler, Matthias, Veillon, Rémi, Wannesson, Luciano, Diebold, Joachim, Zalcman, Gérard, Filleron, Thomas, and Mazières, Julien

Published
2015
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37. Association of Medical Comorbidities With Objective Functional Impairment in Lumbar Degenerative Disc Disease

Author

Staartjes, Victor E; https://orcid.org/0000-0003-1039-2098, Joswig, Holger; https://orcid.org/0000-0003-3540-3910, Corniola, Marco V, Schaller, Karl, Gautschi, Oliver P, Stienen, Martin N; https://orcid.org/0000-0002-6417-1787, Staartjes, Victor E; https://orcid.org/0000-0003-1039-2098, Joswig, Holger; https://orcid.org/0000-0003-3540-3910, Corniola, Marco V, Schaller, Karl, Gautschi, Oliver P, and Stienen, Martin N; https://orcid.org/0000-0002-6417-1787

Abstract

STUDY DESIGN Analysis of a prospective 2-center database. OBJECTIVES Medical comorbidities co-determine clinical outcome. Objective functional impairment (OFI) provides a supplementary dimension of patient assessment. We set out to study whether comorbidities are associated with the presence and degree of OFI in this patient population. METHODS Patients with degenerative diseases of the spine preoperatively performed the timed-up-and-go (TUG) test and a battery of questionnaires. Comorbidities were quantified using the Charlson Comorbidity Index (CCI) and the American Society of Anesthesiology (ASA) grading. Crude and adjusted linear regression models were fitted. RESULTS Of 375 included patients, 97 (25.9%) presented at least some degree of medical comorbidity according to the CCI, and 312 (83.2%) according to ASA grading. In the univariate analysis, the CCI was inconsistently associated with OFI. Only patients with low-grade CCI comorbidity displayed significantly higher TUG test times (p = 0.004). In the multivariable analysis, this effect persisted for patients with CCI = 1 (p = 0.030). Regarding ASA grade, patients with ASA = 3 exhibited significantly increased TUG test times (p = 0.003) and t-scores (p = 0.015). This effect disappeared after multivariable adjustment (p = 0.786 and p = 0.969). In addition, subjective functional impairment according to ODI, and EQ5D index was moderately associated with comorbidities according to ASA (all p < 0.05). CONCLUSION The degree of medical comorbidities appears only weakly and inconsistently associated with OFI in patients scheduled for degenerative lumbar spine surgery, especially after controlling for potential confounders. TUG testing may be valid even in patients with relatively severe comorbidities who are able to complete the test.

Published
2022

38. Distance to first symptoms measured by the 6-min walking test differentiates between treatment success and failure in patients with degenerative lumbar disorders

Author

Zeitlberger, Anna Maria, Sosnova, Marketa, Ziga, Michal, Gautschi, Oliver P, Regli, Luca, Bozinov, Oliver, Weyerbrock, Astrid, Stienen, Martin N, Maldaner, Nicolai, University of Zurich, and Maldaner, Nicolai

Subjects
10180 Clinic for Neurosurgery, 2732 Orthopedics and Sports Medicine, Lumbar Vertebrae, Treatment Outcome, Humans, Reproducibility of Results, 610 Medicine & health, Orthopedics and Sports Medicine, Surgery, Patient Reported Outcome Measures, Walking, 2746 Surgery
Abstract

Purpose The smartphone-based 6-min walking test (6WT) is an established digital outcome measure in patients undergoing surgery for degenerative lumbar disorders (DLD). In addition to the 6WTs primary outcome measure, the 6-min walking distance (6WD), the patient’s distance to first symptoms (DTFS) and time to first symptoms (TTFS) can be recorded. This is the first study to analyse the psychometric properties of the DTFS and TTFS. Methods Forty-nine consecutive patients (55 ± 15.8 years) completed the 6WT pre- and 6 weeks (W6) postoperative. DTFS and TTFS were assessed for reliability and content validity using disease-specific patient-reported outcome measures. The Zurich Claudication Questionnaire patient satisfaction subscale was used as external criterion for treatment success. Internal and external responsiveness for both measures at W6 was evaluated. Results There was a significant improvement in DTFS and TTFS from baseline to W6 (p β = 0.86, 95% CI 0.81–0.90 and β = 0.83, 95% CI 0.76–0.87, both p Conclusion Change in DTFS can differentiate between satisfied and unsatisfied patients after spine surgery. Digital outcome measures on the 6WT metric provide spine surgeons and researchers with a mean to assess their patient’s functional disability and response to surgical treatment in DLD.

Published
2022
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43. Intracranial Efficacy of Selpercatinib in RET Fusion-Positive Non-Small Cell Lung Cancers on the LIBRETTO-001 Trial

Author

Subbiah, Vivek, Gainor, Justin F, Oxnard, Geoffrey R, Tan, Daniel SW, Owen, Dwight H, Cho, Byoung Chul, Loong, Herbert H, McCoach, Caroline E, Weiss, Jared, Kim, Yu Jung, Bazhenova, Lyudmila, Park, Keunchil, Daga, Haruko, Besse, Benjamin, Gautschi, Oliver, Rolfo, Christian, Zhu, Edward Y, Kherani, Jennifer F, Huang, Xin, Kang, Suhyun, and Drilon, Alexander

Subjects
Adult, Male, Lung Neoplasms, Pyridines, Clinical Trials and Supportive Activities, Oncology and Carcinogenesis, Clinical Research, 80 and over, Humans, Oncology & Carcinogenesis, Non-Small-Cell Lung, Lung, Aged, Cancer, Brain Neoplasms, Carcinoma, Proto-Oncogene Proteins c-ret, Lung Cancer, Neurosciences, Evaluation of treatments and therapeutic interventions, Middle Aged, Brain Disorders, Treatment Outcome, 6.1 Pharmaceuticals, Pyrazoles, Female
Abstract

PurposeWe report the intracranial efficacy of selpercatinib, a highly potent and selective RET inhibitor, approved in the United States for RET fusion-positive non-small cell lung cancers (NSCLC).Patients and methodsIn the global phase 1/2 LIBRETTO-001 trial (NCT03157128) in advanced RET-altered solid tumors, selpercatinib was dosed orally (160 mg twice every day) in 28-day cycles. Patients with baseline intracranial metastases had MRI/CT scans every 8 weeks for 1 year (12 weeks thereafter). In this pre-planned analysis of patients with RET fusion-positive NSCLC with baseline intracranial metastases, the primary endpoint was independently assessed intracranial objective response rate (ORR) per RECIST 1.1. Secondary endpoints included intracranial disease control rate, intracranial duration of response, and intracranial progression-free survival (PFS) independently reviewed.ResultsEighty patients with NSCLC had brain metastases at baseline. Patients were heavily pretreated (median = 2 systemic therapies, range = 0-10); 56% of patients received ≥1 course of intracranial radiation (14% whole brain radiotherapy, 45% stereotactic radiosurgery). Among 22 patients with measurable intracranial disease at baseline, intracranial ORR was 82% [95% confidence interval (CI), 60-95], including 23% with complete responses. Among all intracranial responders (measurable and nonmeasurable, n = 38), median duration of intracranial response was not reached (95% CI, 9.3-NE) at a median duration of follow-up of 9.5 months (IQR = 5.7, 12.0). At 12 months, 55% of intracranial responses were ongoing. In all 80 patients, median intracranial PFS was 13.7 months (95% CI, 10.9-NE) at a median duration of follow-up of 11.0 months (IQR = 7.4, 16.5). No new safety signals were revealed in patients with brain metastases compared with the full NSCLC trial population.ConclusionsSelpercatinib has robust and durable intracranial efficacy in patients with RET fusion-positive NSCLC.

Published
2021

44. Clinicopathological Characteristics of RET Rearranged Lung Cancer in European Patients

Author

Michels, Sebastian, Scheel, Andreas Hans, Scheffler, Matthias, Schultheis, Anne Maria, Gautschi, Oliver, Aebersold, Franziska, Diebold, Joachim, Pall, Georg, Rothschild, Sacha, Bubendorf, Lukas, Hartmann, Wolfgang, Heukamp, Lukas, Schildhaus, Hans-Ulrich, Fassunke, Jana, Ihle, Michaela Angelika, Künstlinger, Helen, Heydt, Carina, Fischer, Rieke, Nogovà, Lucia, Mattonet, Christian, Hein, Rebecca, Adams, Anne, Gerigk, Ulrich, Schulte, Wolfgang, Lüders, Heike, Grohé, Christian, Graeven, Ullrich, Müller-Naendrup, Clemens, Draube, Andreas, Kambartel, Karl-Otto, Krüger, Stefan, Schulze-Olden, Susanne, Serke, Monika, Engel-Riedel, Walburga, Kaminsky, Britta, Randerath, Winfried, Merkelbach-Bruse, Sabine, Büttner, Reinhard, and Wolf, Jürgen

Published
2016
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