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2. Chemotherapy and radiotherapy in locally advanced head and neck cancer: an individual patient data network meta-analysis

Author

Adelstein, D.J., Agarwal, J., Alfonsi, M., Argiris, A., Aupérin, A., Bacigalupo, A., Bar-Ad, V., Bartelink, H., Beadle, B., Belkacemi, Y., Bensadoun, R.J., Bernier, J., Blanchard, P., Bourhis, J., Bratland, Å., Brizel, D., Budach, V., Budach, W., Burtness, B., Calais, G., Campbell, B., Caudell, J., Chabaud, S., Chamorey, E., Chaukar, D., Cheugoua-Zanetsie, M., Cho, K.H., Choussy, O., Cruz Hernandez, J.J., Denham, J.W., Dobrowsky, W., Dominello, M.M, Driessen, C.M.L., Fallai, C., Forastiere, A.A., Fortpied, C., Fountzilas, G., Garaud, P., Garden, A.S., Gery, B., Ghadjar, P., Ghi, M.G., Ghosh Laskar, S., Graff-Cailleaud, P., Grau, C., Gregoire, V., Hackshaw, A., Haddad, E, Haffty, B.G., Hansen, A., Hay, J.H., Hayoz, S., Horiot, J.C., Hitt, R., Jeremic, B., Johansen, J., Jones, C., Julieron, M., Kristensen, C.A., Kumar, S., Lacas, B., Langendijk, J.A., Lapeyre, M., Lartigau, E., Licitra, L., Le, Q.T., Lee, J.W., Lee, P., Lewin, F., Li, Y., Lopes, A., Lotayef, M., Maciejewski, B., Mazeron, J.J., Mehta, S., Michalski, W., Moon, J., Moon, S.H., Moyal, E., Nankivell, M., Nilsson, P., Olmi, P., Orecchia, R., O'Sullivan, B., Overgaard, J., Parmar, M.K.B., Petit, C., Pignon, J.P., Pointreau, Y., Posner, M.R., Poulsen, M.G., Quon, H., Racadot, S., Rosenthal, D.I., Rovea, P., Ruo Redda, M.G., Sanguineti, G., Shenouda, G., Simes, J., Sharma, A., Simon, C., Sire, C., Skladowski, K., Spencer, S., Staar, S., Strojan, P., Stromberger, C., Suwinski, R., Szutkowski, Z., Takácsi-Nagy, Z., Tao, Y.G., Temam, S., Thomson, D., Tobias, J.S., Torres-Saavedra, P., Torri, V., Tripcony, L., Trotti, A., Tseroni, V., van Herpen, C., van Tinteren, H., Vermorken, J., Viegas, C.M.P., Vokes, E.E., Waldron, J., Wernecke, K.D, Widder, J., Wolf, G.T., Wong, S.J., Wu, J.S., Yamazaki, H., Zaktonik, B., Zackrisson, B., Zhong, L.P., Petit, Claire, Lacas, Benjamin, Pignon, Jean-Pierre, Le, Quynh Thu, Grégoire, Vincent, Grau, Cai, Hackshaw, Allan, Zackrisson, Björn, Parmar, Mahesh K B, Lee, Ju-Whei, Ghi, Maria Grazia, Sanguineti, Giuseppe, Temam, Stéphane, Cheugoua-Zanetsie, Maurice, O'Sullivan, Brian, Posner, Marshall R, Vokes, Everett E, Cruz Hernandez, Juan J, Szutkowski, Zbigniew, Lartigau, Eric, Budach, Volker, Suwiński, Rafal, Poulsen, Michael, Kumar, Shaleen, Ghosh Laskar, Sarbani, Mazeron, Jean-Jacques, Jeremic, Branislav, Simes, John, Zhong, Lai-Ping, Overgaard, Jens, Fortpied, Catherine, Torres-Saavedra, Pedro, Bourhis, Jean, Aupérin, Anne, and Blanchard, Pierre

Published
2021
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3. Biomarkers predict enhanced clinical outcomes with afatinib versus methotrexate in patients with second-line recurrent and/or metastatic head and neck cancer

Author

Cohen, EEW, Licitra, LF, Burtness, B, Fayette, J, Gauler, T, Clement, PM, Grau, JJ, del Campo, JM, Mailliez, A, Haddad, RI, Vermorken, JB, Tahara, M, Guigay, J, Geoffrois, L, Merlano, MC, Dupuis, N, Krämer, N, Cong, XJ, Gibson, N, Solca, F, Ehrnrooth, E, and Machiels, J-PH

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Dental/Oral and Craniofacial Disease, Rare Diseases, Cancer, Clinical Research, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Administration, Intravenous, Administration, Oral, Afatinib, Antimetabolites, Antineoplastic, Biomarkers, Tumor, Biopsy, Carcinoma, Squamous Cell, Disease-Free Survival, Head and Neck Neoplasms, Humans, Methotrexate, Neoplasm Metastasis, Neoplasm Recurrence, Local, Predictive Value of Tests, Quinazolines, Squamous Cell Carcinoma of Head and Neck, afatinib, methotrexate, HNSCC, biomarker, phase III, EGFR, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundIn the phase III LUX-Head & Neck 1 (LUX-H&N1) trial, second-line afatinib significantly improved progression-free survival (PFS) versus methotrexate in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Here, we evaluated association of prespecified biomarkers with efficacy outcomes in LUX-H&N1.Patients and methodsRandomized patients with R/M HNSCC and progression following ≥2 cycles of platinum therapy received afatinib (40 mg/day) or methotrexate (40 mg/m2/week). Tumor/serum samples were collected at study entry for patients who volunteered for inclusion in biomarker analyses. Tumor biomarkers, including p16 (prespecified subgroup; all tumor subsites), EGFR, HER2, HER3, c-MET and PTEN, were assessed using tissue microarray cores and slides; serum protein was evaluated using the VeriStrat® test. Biomarkers were correlated with efficacy outcomes.ResultsOf 483 randomized patients, 326 (67%) were included in the biomarker analyses; baseline characteristics were consistent with the overall study population. Median PFS favored afatinib over methotrexate in patients with p16-negative [2.7 versus 1.6 months; HR 0.70 (95% CI 0.50-0.97)], EGFR-amplified [2.8 versus 1.5 months; HR 0.53 (0.33-0.85)], HER3-low [2.8 versus 1.8 months; HR 0.57 (0.37-0.88)], and PTEN-high [1.6 versus 1.4 months; HR 0.55 (0.29-1.05)] tumors. Afatinib also improved PFS in combined subsets of patients with p16-negative and EGFR-amplified tumors [2.7 versus 1.5 months; HR 0.47 (0.28-0.80)], and patients with p16-negative tumors who were EGFR therapy-naïve [4.0 versus 2.4 months; HR 0.55 (0.31-0.98)]. PFS was improved in afatinib-treated patients who were VeriStrat 'Good' versus 'Poor' [2.7 versus 1.5 months; HR 0.71 (0.49-0.94)], but no treatment interaction was observed. Afatinib improved tumor response versus methotrexate in all subsets analyzed except for those with p16-positive disease (n = 35).ConclusionsSubgroups of HNSCC patients who may achieve increased benefit from afatinib were identified based on prespecified tumor biomarkers (p16-negative, EGFR-amplified, HER3-low, PTEN-high). Future studies are warranted to validate these findings.Clinical trial registrationNCT01345682.

Published
2017

4. Health-Related Quality of Life (HRQoL) Data From KEYNOTE-412: Chemoradiotherapy (CRT) with or Without Pembrolizumab (pembro) in Patients (pts) with Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)

Author

Machiels, J.P., primary, TAO, Y., additional, Burtness, B., additional, Tahara, M., additional, Rischin, D., additional, Alves, G.V., additional, Lima, I.P. Figueiredo, additional, Hughes, B.G.M., additional, Pointreau, Y., additional, Aksoy, S., additional, Laban, S., additional, Greil, R., additional, Burian, M., additional, Hetnal, M., additional, Licitra, L., additional, Black, C.M., additional, Norquist, J., additional, Gumuscu, B., additional, Bidadi, B., additional, and Siu, L.L., additional

Published
2024
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5. Lenvatinib ± Pembrolizumab Versus Chemotherapy for Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That Progressed after Platinum and Immunotherapy: The Phase 2 LEAP-009 Study

Author

Harrington, K., primary, Kim, H.R., additional, Salas, S., additional, Oliva, M., additional, Metcalf, R., additional, Bernsdorf, M., additional, Kim, J.W., additional, Cohen, E., additional, Siu, L.L., additional, Rischin, D., additional, Licitra, L., additional, Vermorken, J., additional, Le, Q.T., additional, Tahara, M., additional, Machiels, J.P., additional, O'Hara, K., additional, Pathiraja, K., additional, Gumuscu, B., additional, Bidadi, B., additional, and Burtness, B., additional

Published
2024
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6. A Phase 1 Dose-escalation and Expansion Study of CUE-101, Given As Monotherapy in 3rd Line and in Combination with Pembrolizumab in 1st Line Recurrent/Metastatic (R/M) HPV16+ Head and Neck Cancer Patients

Author

Colevas, A.D., primary, Chung, C.H., additional, Adkins, D., additional, Rodriguez, C.P., additional, Park, J.C., additional, Gibson, M.K., additional, Sukari, A., additional, Burtness, B., additional, Johnson, F.M., additional, Julian, R.A., additional, Saba, N.F., additional, Worden, F., additional, Dunn, L., additional, Seiwert, T.Y., additional, Jotte, R.M., additional, Haddad, R., additional, Gabrail, N., additional, Bauman, J., additional, Margossian, S.P., additional, and Pai, S.I., additional

Published
2024
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7. Head and neck cancers, version 1.2015 featured updates to the NCCN guidelines

Author

Pfister, DG, Spencer, S, Brizel, DM, Burtness, B, Busse, PM, Caudell, JJ, Cmelak, AJ, Colevas, AD, Dunphy, F, Eisele, DW, Foote, RL, Gilbert, J, Gillison, ML, Haddad, RI, Haughey, BH, Hicks, WL, Hitchcock, YJ, Jimeno, A, Kies, MS, Lydiatt, WM, Maghami, E, McCaffrey, T, Mell, LK, Mittal, BB, Pinto, HA, Ridge, JA, Rodriguez, CP, Samant, S, Shah, JP, Weber, RS, Wolf, GT, Worden, F, Yom, SS, McMillian, N, and Hughes, M

Subjects
Oncology & Carcinogenesis
Abstract

These NCCN Guidelines Insights focus on recent updates to the 2015 NCCN Guidelines for Head and Neck (H&N) Cancers. These Insights describe the different types of particle therapy that may be used to treat H&N cancers, in contrast to traditional radiation therapy (RT) with photons (x-ray). Research is ongoing regarding the different types of particle therapy, including protons and carbonions, with the goals of reducing the long-term side effects from RT and improving the therapeutic index. For the 2015 update, the NCCN H&N Cancers Panel agreed to delete recommendations for neutron therapy for salivary gland cancers, because of its limited availability, which has decreased over the past 2 decades; the small number of patients in the United States who currently receive this treatment; and concerns that the toxicity of neutron therapy may offset potential disease control advantages.

Published
2015

8. A 3′-UTR KRAS-variant is associated with cisplatin resistance in patients with recurrent and/or metastatic head and neck squamous cell carcinoma

Author

Chung, CH, Lee, JW, Slebos, RJ, Howard, JD, Perez, J, Kang, H, Fertig, EJ, Considine, M, Gilbert, J, Murphy, BA, Nallur, S, Paranjape, T, Jordan, RC, Garcia, J, Burtness, B, Forastiere, AA, and Weidhaas, JB

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Orphan Drug, Cancer Genomics, Precision Medicine, Clinical Research, Human Genome, Cancer, Digestive Diseases, Genetics, Dental/Oral and Craniofacial Disease, Clinical Trials and Supportive Activities, Rare Diseases, 3' Untranslated Regions, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Carcinoma, Squamous Cell, Cetuximab, Cisplatin, Cyclin-Dependent Kinase Inhibitor p16, Disease-Free Survival, Drug Resistance, Neoplasm, Female, Gene Expression Regulation, Neoplastic, Genotype, Head and Neck Neoplasms, Humans, Male, Middle Aged, Neoplasm Metastasis, Neoplasm Recurrence, Local, Prognosis, Proto-Oncogene Proteins, Proto-Oncogene Proteins p21(ras), Squamous Cell Carcinoma of Head and Neck, ras Proteins, KRAS-variant, cisplatin, cetuximab, p16 expression, head and neck squamous cell carcinoma, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundA germline mutation in the 3'-untranslated region of KRAS (rs61764370, KRAS-variant: TG/GG) has previously been associated with altered patient outcome and drug resistance/sensitivity in various cancers. We examined the prognostic and predictive significance of this variant in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).Patients and methodsWe conducted a retrospective study of 103 HNSCCs collected from three completed clinical trials. KRAS-variant genotyping was conducted for these samples and 8 HNSCC cell lines. p16 expression was determined in a subset of 26 oropharynx tumors by immunohistochemistry. Microarray analysis was also utilized to elucidate differentially expressed genes between KRAS-variant and non-variant tumors. Drug sensitivity in cell lines was evaluated to confirm clinical findings.ResultsKRAS-variant status was determined in 95/103 (92%) of the HNSCC tumor samples and the allelic frequency of TG/GG was 32% (30/95). Three of the HNSCC cell lines (3/8) studied had the KRAS-variant. No association between KRAS-variant status and p16 expression was observed in the oropharynx subset (Fisher's exact test, P = 1.0). With respect to patient outcome, patients with the KRAS-variant had poor progression-free survival when treated with cisplatin (log-rank P = 0.002). Conversely, KRAS-variant patients appeared to experience some improvement in disease control when cetuximab was added to their platinum-based regimen (log-rank P = 0.04).ConclusionsThe TG/GG rs61764370 KRAS-variant is a potential predictive biomarker for poor platinum response in R/M HNSCC patients.Clinical trial registration numbersNCT00503997, NCT00425750, NCT00003809.

Published
2014

9. 106P Treatment sequencing in PD-L1–positive recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): Exploratory analysis of the phase III KEYNOTE-048 study

Author

Greil, R., primary, Burtness, B., additional, Laban, S., additional, Braña, I., additional, Mesia Nin, R., additional, Fuereder, T., additional, Bratland, Å., additional, Licitra, L.F.L., additional, Rordorf, T., additional, Psyrri, A., additional, Popovtzer, A., additional, Hughes, B., additional, Tahara, M., additional, Lin, J., additional, Gumuscu, B., additional, Lerman, N., additional, and Harrington, K.J., additional

Published
2023
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10. Results of MDR-1 Vector Modification Trial Indicate that Granulocyte/Macrophage Colony-Forming Unit Cells Do not Contribute to Posttransplant Hematopoietic Recovery Following Intensive Systemic Therapy

Author

Hanania, E. G., Giles, R. E., Kavanagh, J., Ellerson, D., Zu, Z., Wang, T., Su, Y., Kudelka, A., Rahman, Z., Holmes, F., Hortobagyi, G., Claxton, D., Bachier, C., Thall, P., Cheng, S., Hester, J., Ostrove, J. M., Bird, R. E., Chang, A., Korbling, M., Seong, D., Cote, R., Holzmayer, T., Mechetner, E., Heimfeld, S., Berenson, R., Burtness, B., Edwards, C., Bast, R., Andreeff, M., Champlin, R., and Deisseroth, A. B.

Published
1996

11. Cytosine Deaminase Adenoviral Vector and 5-Fluorocytosine Selectively Reduce Breast Cancer Cells 1 Million-Fold When They Contaminate Hematopoietic Cells: A Potential Purging Method for Autologous Transplantation

Author

Garcia-Sanchez, F, Pizzorno, G, Fu, SQ, Nanakorn, T, Krause, DS, Liang, J, Adams, E, Leffert, JJ, Yin, LH, Cooperberg, MR, Hanania, E, Wang, WL, Won, JH, Peng, XY, Cote, R, Brown, R, Burtness, B, Giles, R, Crystal, R, and Deisseroth, AB

Subjects
Transplantation, Stem Cell Research - Nonembryonic - Human, Genetics, Stem Cell Research, Breast Cancer, Cancer, 5.2 Cellular and gene therapies, Development of treatments and therapeutic interventions, Infection, Adenoviridae, Animals, Antimetabolites, Antineoplastic, Breast Neoplasms, Cell Death, Cytosine Deaminase, Female, Flucytosine, Fluorouracil, Gene Transfer Techniques, Genetic Vectors, Hematopoietic Stem Cell Mobilization, Hematopoietic Stem Cell Transplantation, Hematopoietic Stem Cells, Humans, Male, Mice, Nucleoside Deaminases, Prodrugs, Transplantation, Autologous, Tumor Cells, Cultured, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Paediatrics and Reproductive Medicine, Immunology
Abstract

Ad.CMV-CD is a replication incompetent adenoviral vector carrying a cytomegalovirus (CMV)-driven transcription unit of the cytosine deaminase (CD) gene. The CD transcription unit in this vector catalyzes the deamination of the nontoxic pro-drug, 5-fluorocytosine (5-FC), thus converting it to the cytotoxic drug 5-fluorouracil (5-FU). This adenoviral vector prodrug activation system has been proposed for use in selectively sensitizing breast cancer cells, which may contaminate collections of autologous stem cells products from breast cancer patients, to the toxic effects of 5-FC, without damaging the reconstitutive capability of the normal hematopoietic cells. This system could conceivably kill even the nondividing breast cancer cells, because the levels of 5-FU generated by this system are 10 to 30 times that associated with systemic administration of 5-FU. The incorporation of 5-FU into mRNA at these high levels is sufficient to disrupt mRNA processing and protein synthesis so that even nondividing cells die of protein starvation. To test if the CD adenoviral vector sensitizes breast cancer cells to 5-FC, we exposed primary explants of normal human mammary epithelial cells (HMECs) and the established breast cancer cell (BCC) lines MCF-7 and MDA-MB-453 to the Ad.CMV-CD for 90 minutes. This produced a 100-fold sensitization of these epithelial cells to the effects of 48 hours of exposure to 5-FC. We next tested the selectivity of this system for BCC. When peripheral blood mononuclear cells (PBMCs), collected from cancer patients during the recovery phase from conventional dose chemotherapy-induced myelosuppression, were exposed to the Ad.CMV-CD for 90 minutes in serum-free conditions, little or no detectable conversion of 5-FC into 5-FU was seen even after 48 hours of exposure to high doses of 5-FC. In contrast, 70% of 5-FC was converted into the cytotoxic agent 5-FU when MCF-7 breast cancer cells (BCCs) were exposed to the same Ad.CMV-CD vector followed by 5-FC for 48 hours. All of the BCC lines tested were shown to be sensitive to infection by adenoviral vectors when exposed to a recombinant adenoviral vector containing the reporter gene betagalactosidase (Ad.CMV-betagal). In contrast, less than 1% of the CD34-selected cells and their more immature subsets, such as the CD34+CD38- or CD34(+)CD33- subpopulations, were positive for infection by the Ad.CMV-betagal vector, as judged by fluorescence-activated cell sorting (FACS) analysis, when exposed to the adenoviral vector under conditions that did not commit the early hematopoietic precursor cells to maturation. When artificial mixtures of hematopoietic cells and BCCs were exposed for 90 minutes to the Ad.CMV-CD vector and to 5-FC for 10 days or more, a greater than 1 million fold reduction in the number of BCCs, as measured by colony-limiting dilution assays, was observed. To test if the conditions were damaging for the hematopoietic reconstituting cells, marrow cells collected from 5-FU-treated male donor mice were incubated with the cytosine deaminase adenoviral vector and then exposed to 5-FC either for 4 days in vitro before transplantation or for 14 days immediately after transplantation in vivo. There was no significant decrease in the reconstituting capability of the male marrow cells, as measured by their persistence in female irradiated recipients for up to 6 months after transplantation. These observations suggest that adenovirus-mediated gene transfer of the Escherichia coli cytosine deaminase gene followed by exposure to the nontoxic pro-drug 5-FC may be a potential strategy to selectively reduce the level of contaminating BCCs in collections of hematopoietic cells used for autografts in breast cancer patients.

Published
1998

12. 27O First-in-class first-in-human phase I trial of RBN-2397 in patients with advanced solid tumors validates PARP7 as a novel anticancer therapeutic target

Author

Yap, T.A., primary, Cervantes, A., additional, Falchook, G., additional, Patel, M., additional, Juric, D., additional, Waqar, S.N., additional, Schenk, E., additional, Shapiro, G., additional, Boni, V., additional, Perez, C.A., additional, Burtness, B., additional, Najjar, Y., additional, Racca, F.E., additional, Rojas Laimito, K.I., additional, Kuplast-Barr, K., additional, McEachern, K., additional, Samant, M., additional, Bozón, V., additional, Parasuraman, S., additional, and Johnson, M.L., additional

Published
2023
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13. Screening for Extranodal Extension with Deep Learning: Evaluation in ECOG-ACRIN E3311, a Randomized De-Escalation Trial for HPV-Associated Oropharyngeal Carcinoma

Author

Kann, B.H., primary, Likitlersuang, J., additional, Ye, Z., additional, Aneja, S., additional, Bakst, R.L., additional, Kelly, H.R., additional, Juliano, A., additional, Payabvash, S., additional, Guenette, J.P., additional, Uppaluri, R., additional, Margalit, D.N., additional, Schoenfeld, J.D., additional, Tishler, R.B., additional, Haddad, R.I., additional, Aerts, H., additional, Garcia, J.J., additional, Flamand, Y., additional, Subramaniam, R.M., additional, Burtness, B., additional, and Ferris, R.L., additional

Published
2022
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14. Reduced Aspiration Rates for 50 Gy Postoperative Radiation in HPV-Associated Oropharynx Cancer in E3311: A Trial of the ECOG-ACRIN Cancer Research Group

Author

Hutcheson, K.A., primary, Peterson, C.B., additional, Barbon, C.E., additional, Quon, H., additional, Mehra, R., additional, Ringash, J.G., additional, Lewin, J.S., additional, Flamand, Y., additional, Duvvuri, U., additional, Ozer, E., additional, Thomas, G.R., additional, Kupferman, M.E., additional, Koch, W., additional, Bell, R.B., additional, Saba, N.F., additional, Panwar, A., additional, Annino Jr, D.J., additional, Wagner, L.I., additional, Ferris, R.L., additional, and Burtness, B., additional

Published
2022
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16. LBA5 Primary results of the phase III KEYNOTE-412 study: Pembrolizumab (pembro) with chemoradiation therapy (CRT) vs placebo plus CRT for locally advanced (LA) head and neck squamous cell carcinoma (HNSCC)

Author

Machiels, J-P., primary, Tao, Y., additional, Burtness, B., additional, Tahara, M., additional, Rischin, D., additional, Alves, G.V., additional, Lima, I.P.F., additional, Hughes, B.G.M., additional, Pointreau, Y., additional, Aksoy, S., additional, Laban, S., additional, Greil, R., additional, Burian, M., additional, Hetnal, M., additional, Licitra, L.F., additional, Swaby, R., additional, Zhang, Y., additional, Gumuscu, B., additional, Bidadi, B., additional, and Siu, L.L., additional

Published
2022
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17. 658MO Pembrolizumab (pembro) vs standard-of-care (SOC) in previously treated recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): 6-year follow-up of KEYNOTE-040

Author

Soulieres, D., primary, Harrington, K.J., additional, Le Tourneau, C., additional, Silva, J.D., additional, Licitra, L.F., additional, Ahn, M-J., additional, Soria, A., additional, Machiels, J-P., additional, Mach, N., additional, Mehra, R., additional, Burtness, B., additional, Lin, J., additional, Lerman, N., additional, Gumuscu, B., additional, and Cohen, E.E.W., additional

Published
2022
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18. 659MO Pembrolizumab with or without chemotherapy for first-line treatment of recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): 5-year results from KEYNOTE-048

Author

Tahara, M., primary, Greil, R., additional, Rischin, D., additional, Harrington, K.J., additional, Burtness, B., additional, De Castro, G., additional, Psyrri, A., additional, Brana, I., additional, Neupane, P., additional, Bratland, Å., additional, Fuereder, T., additional, Hughes, B.G.M., additional, Mesia Nin, R., additional, Ngamphaiboon, N., additional, Rordorf, T., additional, Wan Ishak, W.Z., additional, Lin, J., additional, Gumuscu, B., additional, Lerman, N., additional, and Soulieres, D., additional

Published
2022
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24. 850MO Phase II randomized trial of chemotherapy followed by surgery and PORT versus surgery and PORT for organ preservation of T3 and T4a (selected T4b) sinonasal squamous cell carcinoma (SNC): A trial of the ECOG-ACRIN cancer research group (EA3163)

Author

Saba, N.F., Flamand, Y., Lin, D.T., Chung, C.H., McDonald, M.W., Flampouri, S., Khan, S.A., Snyderman, C.H., Hanna, E., El-Sayed, Y.H., Solares, C.A., Duan, F., Ho, A.L., Samuels, M.A., Swiecicki, P.L., Subramaniam, R.M., Chakravarthy, A., and Burtness, B.

Published
2024
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25. Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048

Author

Rischin, D, Harrington, KJ, Greil, R, Soulieres, D, Tahara, M, de Castro Jr, G, Psyrri, A, Brana, I, Neupane, P, Bratland, A, Fuereder, T, Hughes, BGM, Mesia, R, Ngamphaiboon, N, Rordorf, T, Ishak, WZW, Hong, R-L, Mendoza, RG, Jia, L, Chirovsky, D, Norquist, J, Jin, F, Burtness, B, Rischin, D, Harrington, KJ, Greil, R, Soulieres, D, Tahara, M, de Castro Jr, G, Psyrri, A, Brana, I, Neupane, P, Bratland, A, Fuereder, T, Hughes, BGM, Mesia, R, Ngamphaiboon, N, Rordorf, T, Ishak, WZW, Hong, R-L, Mendoza, RG, Jia, L, Chirovsky, D, Norquist, J, Jin, F, and Burtness, B

Abstract

OBJECTIVES: To assess health-related quality of life (HRQoL) with first-line pembrolizumab, pembrolizumab-chemotherapy, or cetuximab-chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the phase 3 KEYNOTE-048 trial (NCT02358031). MATERIALS AND METHODS: HRQoL was measured using the European Organisation for Research and Treatment of Cancer 30-question quality-of-life (EORTC QLQ-C30), the EORTC 35-question quality-of-life head and neck cancer-specific module (EORTC QLQ-H&N35), and the EuroQol 5-dimension 3-level instruments (EQ-5D-3L). Secondary endpoints included mean change from baseline in EORTC QLQ-C30 global health status/quality of life (GHS/QoL) at week 15 and time to deterioration (TTD) in EORTC QLQ-C30 GHS/QoL and EORTC QLQ-H&N35 pain and swallowing. RESULTS: Of 882 enrolled participants, 844 received ≥ 1 dose of study treatment and completed ≥ 1 HRQoL assessment; adherence was ≥ 79% at week 15 across treatment groups. At week 15, EORTC QLQ-C30 GHS/QoL scores remained stable; no clinically meaningful between-group differences were observed (least squares mean difference, pembrolizumab vs cetuximab-chemotherapy, 0.24; 95% CI, -3.34 to 3.82; pembrolizumab-chemotherapy vs cetuximab-chemotherapy, 0.40; 95% CI, -3.46 to 4.26). Median TTD in EORTC QLQ-C30 GHS/QoL and EORTC QLQ-H&N35 pain and swallowing scores was not reached over 51 weeks across groups, showing stable HRQoL. TTD was similar between groups for EORTC QLQ-C30 GHS/QoL (pembrolizumab vs cetuximab-chemotherapy: HR, 1.38; 95% CI, 0.95-2.00; pembrolizumab-chemotherapy vs cetuximab-chemotherapy: HR, 1.37; 95% CI, 0.94-2.00), as was TTD in EORTC QLQ-H&N35 pain and swallowing scores. CONCLUSIONS: Pembrolizumab monotherapy and pembrolizumab-chemotherapy extended OS while maintaining HRQoL, further supporting first-line use for R/M HNSCC.

Published
2022

26. Pembrolizumab Alone or With Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score

Author

Burtness, B, Rischin, D, Greil, R, Soulieres, D, Tahara, M, de Castro Jr, G, Psyrri, A, Brana, I, Baste, N, Neupane, P, Bratland, A, Fuereder, T, Hughes, BGM, Mesia, R, Ngamphaiboon, N, Rordorf, T, Wan Ishak, WZ, Ge, J, Swaby, RF, Gumuscu, B, Harrington, K, Burtness, B, Rischin, D, Greil, R, Soulieres, D, Tahara, M, de Castro Jr, G, Psyrri, A, Brana, I, Baste, N, Neupane, P, Bratland, A, Fuereder, T, Hughes, BGM, Mesia, R, Ngamphaiboon, N, Rordorf, T, Wan Ishak, WZ, Ge, J, Swaby, RF, Gumuscu, B, and Harrington, K

Abstract

PURPOSE: The phase III KEYNOTE-048 (ClinicalTrials.gov identifier: NCT02358031) trial of pembrolizumab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) included planned efficacy analyses in the total population and in participants with programmed death ligand-1 (PD-L1) combined positive score (CPS) ≥ 1 and CPS ≥ 20. To further characterize the predictive value of PD-L1 expression on outcome, we conducted efficacy analyses in the PD-L1 CPS < 1 and CPS 1-19 subgroups in KEYNOTE-048. METHODS: Participants with R/M HNSCC and no prior systemic therapy for R/M disease were randomly assigned 1:1:1 to pembrolizumab, pembrolizumab-chemotherapy, or cetuximab-chemotherapy. Post hoc efficacy analyses of the PD-L1 CPS < 1 and CPS 1-19 subgroups were performed. RESULTS: Of 882 participants enrolled, 128 had PD-L1 CPS < 1 and 373 had CPS 1-19. For pembrolizumab versus cetuximab-chemotherapy, the median overall survival was 7.9 versus 11.3 months in the PD-L1 CPS < 1 subgroup (hazard ratio [HR], 1.51 [95% CI, 0.96 to 2.37]) and 10.8 versus 10.1 months in the CPS 1-19 subgroup (HR, 0.86 [95% CI, 0.66 to 1.12]). For pembrolizumab-chemotherapy versus cetuximab-chemotherapy, the median overall survival was 11.3 versus 10.7 months in the PD-L1 CPS < 1 subgroup (HR, 1.21 [95% CI, 0.76 to 1.94]) and 12.7 versus 9.9 months in the CPS 1-19 subgroup (HR, 0.71 [95% CI, 0.54 to 0.94]). CONCLUSION: Increased efficacy of pembrolizumab or pembrolizumab-chemotherapy was observed with increasing PD-L1 expression. PD-L1 CPS < 1 subgroup analysis was limited by small participant numbers. Results from the PD-L1 CPS 1-19 subgroup support previous findings of treatment benefit with pembrolizumab monotherapy and pembrolizumab-chemotherapy in patients with PD-L1 CPS ≥ 1 tumors. Although PD-L1 expression is informative, exploration of additional predictive biomarkers is needed for low PD-L1-expressing HNSCC.

Published
2022

27. Phase 2 LEAP-009: Lenvatinib (Lenva) With or Without Pembrolizumab (Pembro) vs. Chemotherapy (Chemo) for Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That has Progressed on Platinum and Immunotherapy

Author

Harrington, K., primary, Cohen, E., additional, Siu, L., additional, Rischin, D., additional, Licitra, L., additional, Vermorken, J., additional, Le, Q.T., additional, Tahara, M., additional, Machiels, J.P., additional, Hawk, N., additional, Ge, J., additional, Bidadi, B., additional, Swaby, R., additional, and Burtness, B., additional

Published
2022
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30. Phase 1/2 Study of Pepinemab in Combination with Pembrolizumab as First-Line Treatment of Advanced, Recurrent or Metastatic Head and Neck Cancer (KEYNOTE B84)

Author

Fisher, T.L., primary, Evans, E.E., additional, Mallow, C., additional, Foster, A., additional, Boise, M., additional, Smith, E., additional, Leonard, J.E., additional, Chaney, M., additional, Beck, J.T., additional, Hager, S., additional, Saba, N.F., additional, Steuer, C., additional, Adkins, D., additional, Burtness, B., additional, and Zauderer, M., additional

Published
2022
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31. Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048

Author

Rischin, D. Harrington, K.J. Greil, R. Soulières, D. Tahara, M. de Castro Jr, G. Psyrri, A. Braña, I. Neupane, P. Bratland, Å. Fuereder, T. Hughes, B.G.M. Mesía, R. Ngamphaiboon, N. Rordorf, T. Ishak, W.Z.W. Hong, R.-L. Mendoza, R.G. Jia, L. Chirovsky, D. Norquist, J. Jin, F. Burtness, B.

Subjects
otorhinolaryngologic diseases, social sciences, neoplasms, humanities
Abstract

Objectives: To assess health-related quality of life (HRQoL) with first-line pembrolizumab, pembrolizumab-chemotherapy, or cetuximab-chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the phase 3 KEYNOTE-048 trial (NCT02358031). Materials and Methods: HRQoL was measured using the European Organisation for Research and Treatment of Cancer 30-question quality-of-life (EORTC QLQ-C30), the EORTC 35-question quality-of-life head and neck cancer–specific module (EORTC QLQ-H&N35), and the EuroQol 5-dimension 3-level instruments (EQ-5D-3L). Secondary endpoints included mean change from baseline in EORTC QLQ-C30 global health status/quality of life (GHS/QoL) at week 15 and time to deterioration (TTD) in EORTC QLQ-C30 GHS/QoL and EORTC QLQ-H&N35 pain and swallowing. Results: Of 882 enrolled participants, 844 received ≥ 1 dose of study treatment and completed ≥ 1 HRQoL assessment; adherence was ≥ 79% at week 15 across treatment groups. At week 15, EORTC QLQ-C30 GHS/QoL scores remained stable; no clinically meaningful between-group differences were observed (least squares mean difference, pembrolizumab vs cetuximab-chemotherapy, 0.24; 95% CI, −3.34 to 3.82; pembrolizumab-chemotherapy vs cetuximab-chemotherapy, 0.40; 95% CI, −3.46 to 4.26). Median TTD in EORTC QLQ-C30 GHS/QoL and EORTC QLQ-H&N35 pain and swallowing scores was not reached over 51 weeks across groups, showing stable HRQoL. TTD was similar between groups for EORTC QLQ-C30 GHS/QoL (pembrolizumab vs cetuximab-chemotherapy: HR, 1.38; 95% CI, 0.95–2.00; pembrolizumab-chemotherapy vs cetuximab-chemotherapy: HR, 1.37; 95% CI, 0.94–2.00), as was TTD in EORTC QLQ-H&N35 pain and swallowing scores. Conclusions: Pembrolizumab monotherapy and pembrolizumab-chemotherapy extended OS while maintaining HRQoL, further supporting first-line use for R/M HNSCC. © 2022 Merck Sharp & Dohme Corp, The Author(s)

Published
2022

32. Outcomes Stratification of Head and Neck Cancer Using Pre- and Post-Treatment DNA Methylation in Peripheral Blood

Author

Qian, D.C., primary, Ulrich, B.C., additional, Peng, G., additional, Zhao, H., additional, Conneely, K.N., additional, Miller, A.H., additional, Bruner, D.W., additional, Eldridge, R.C., additional, Wommack, E.C., additional, Higgins, K.A., additional, Shin, D.M., additional, Saba, N.F., additional, Smith, A.K., additional, Burtness, B., additional, Park, H.S.M., additional, Stokes, W.A., additional, Beitler, J.J., additional, and Xiao, C., additional

Published
2021
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35. Entwicklung bildbasierter Radiomics-Biomarker für den Humanen Papillomavirus (HPV)-Status beim oropharyngealen Plattenepithelkarzinom (OPSCC) mittels Machine-Learning-Algorithmen

Author

Haider, SP, additional, Mahajan, A, additional, Zeevi, T, additional, Forghani, R, additional, Kann, BH., additional, Judson, BL., additional, Burtness, B, additional, Sharaf, K, additional, Reichel, C, additional, Baumeister, P, additional, and Payabvash, S, additional

Published
2021
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37. Chemotherapy and radiotherapy in locally advanced head and neck cancer: an individual patient data network meta-analysis

Author

Petit, Claire, primary, Lacas, Benjamin, additional, Pignon, Jean-Pierre, additional, Le, Quynh Thu, additional, Grégoire, Vincent, additional, Grau, Cai, additional, Hackshaw, Allan, additional, Zackrisson, Björn, additional, Parmar, Mahesh K B, additional, Lee, Ju-Whei, additional, Ghi, Maria Grazia, additional, Sanguineti, Giuseppe, additional, Temam, Stéphane, additional, Cheugoua-Zanetsie, Maurice, additional, O'Sullivan, Brian, additional, Posner, Marshall R, additional, Vokes, Everett E, additional, Cruz Hernandez, Juan J, additional, Szutkowski, Zbigniew, additional, Lartigau, Eric, additional, Budach, Volker, additional, Suwiński, Rafal, additional, Poulsen, Michael, additional, Kumar, Shaleen, additional, Ghosh Laskar, Sarbani, additional, Mazeron, Jean-Jacques, additional, Jeremic, Branislav, additional, Simes, John, additional, Zhong, Lai-Ping, additional, Overgaard, Jens, additional, Fortpied, Catherine, additional, Torres-Saavedra, Pedro, additional, Bourhis, Jean, additional, Aupérin, Anne, additional, Blanchard, Pierre, additional, Adelstein, D.J., additional, Agarwal, J., additional, Alfonsi, M., additional, Argiris, A., additional, Aupérin, A., additional, Bacigalupo, A., additional, Bar-Ad, V., additional, Bartelink, H., additional, Beadle, B., additional, Belkacemi, Y., additional, Bensadoun, R.J., additional, Bernier, J., additional, Blanchard, P., additional, Bourhis, J., additional, Bratland, Å., additional, Brizel, D., additional, Budach, V., additional, Budach, W., additional, Burtness, B., additional, Calais, G., additional, Campbell, B., additional, Caudell, J., additional, Chabaud, S., additional, Chamorey, E., additional, Chaukar, D., additional, Cheugoua-Zanetsie, M., additional, Cho, K.H., additional, Choussy, O., additional, Cruz Hernandez, J.J., additional, Denham, J.W., additional, Dobrowsky, W., additional, Dominello, M.M, additional, Driessen, C.M.L., additional, Fallai, C., additional, Forastiere, A.A., additional, Fortpied, C., additional, Fountzilas, G., additional, Garaud, P., additional, Garden, A.S., additional, Gery, B., additional, Ghadjar, P., additional, Ghi, M.G., additional, Ghosh Laskar, S., additional, Graff-Cailleaud, P., additional, Grau, C., additional, Gregoire, V., additional, Hackshaw, A., additional, Haddad, E, additional, Haffty, B.G., additional, Hansen, A., additional, Hay, J.H., additional, Hayoz, S., additional, Horiot, J.C., additional, Hitt, R., additional, Jeremic, B., additional, Johansen, J., additional, Jones, C., additional, Julieron, M., additional, Kristensen, C.A., additional, Kumar, S., additional, Lacas, B., additional, Langendijk, J.A., additional, Lapeyre, M., additional, Lartigau, E., additional, Licitra, L., additional, Le, Q.T., additional, Lee, J.W., additional, Lee, P., additional, Lewin, F., additional, Li, Y., additional, Lopes, A., additional, Lotayef, M., additional, Maciejewski, B., additional, Mazeron, J.J., additional, Mehta, S., additional, Michalski, W., additional, Moon, J., additional, Moon, S.H., additional, Moyal, E., additional, Nankivell, M., additional, Nilsson, P., additional, Olmi, P., additional, Orecchia, R., additional, O'Sullivan, B., additional, Overgaard, J., additional, Parmar, M.K.B., additional, Petit, C., additional, Pignon, J.P., additional, Pointreau, Y., additional, Posner, M.R., additional, Poulsen, M.G., additional, Quon, H., additional, Racadot, S., additional, Rosenthal, D.I., additional, Rovea, P., additional, Ruo Redda, M.G., additional, Sanguineti, G., additional, Shenouda, G., additional, Simes, J., additional, Sharma, A., additional, Simon, C., additional, Sire, C., additional, Skladowski, K., additional, Spencer, S., additional, Staar, S., additional, Strojan, P., additional, Stromberger, C., additional, Suwinski, R., additional, Szutkowski, Z., additional, Takácsi-Nagy, Z., additional, Tao, Y.G., additional, Temam, S., additional, Thomson, D., additional, Tobias, J.S., additional, Torres-Saavedra, P., additional, Torri, V., additional, Tripcony, L., additional, Trotti, A., additional, Tseroni, V., additional, van Herpen, C., additional, van Tinteren, H., additional, Vermorken, J., additional, Viegas, C.M.P., additional, Vokes, E.E., additional, Waldron, J., additional, Wernecke, K.D, additional, Widder, J., additional, Wolf, G.T., additional, Wong, S.J., additional, Wu, J.S., additional, Yamazaki, H., additional, Zaktonik, B., additional, Zackrisson, B., additional, and Zhong, L.P., additional

Published
2021
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41. 71P A phase II study of ADU-S100 in combination with pembrolizumab in adult patients with PD-L1+ recurrent or metastatic HNSCC: Preliminary safety, efficacy and PK/PD results

Author

Zandberg, D.P., primary, Ferris, R., additional, Laux, D., additional, Mehra, R., additional, Nabell, L., additional, Kaczmar, J., additional, Gibson, M.K., additional, Kim, Y.J., additional, Neupane, P., additional, Bauman, J., additional, Julian, R., additional, Adkins, D., additional, Cohen, E., additional, Burtness, B., additional, Bermingham, C., additional, Dupage, A., additional, Desbien, A., additional, Loi, A., additional, Nuyten, D.S.A., additional, and Saba, N.F., additional

Published
2020
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42. 915MO Long-term outcomes from KEYNOTE-048: Pembrolizumab (pembro) alone or with chemotherapy (pembro+C) vs EXTREME (E) as first-line (1L) therapy for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)

Author

Greil, R., primary, Rischin, D., additional, Harrington, K.J., additional, Soulières, D., additional, Tahara, M., additional, de Castro, G., additional, Psyrri, A., additional, Baste, N., additional, Neupane, P., additional, Bratland, Å., additional, Fuereder, T., additional, Hughes, B.G.M., additional, Mesia, R., additional, Ngamphaiboon, N., additional, Rordorf, T., additional, Ishak, W.Z. Wan, additional, Lin, J., additional, Swaby, R.F., additional, Gumuscu, B., additional, and Burtness, B., additional

Published
2020
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43. 973TiP LEAP-010: Phase III study of first-line pembrolizumab with or without lenvatinib in patients (pts) with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)

Author

Siu, L.L., primary, Burtness, B., additional, Cohen, E.E., additional, Harrington, K.J., additional, Licitra, L.F., additional, Rischin, D., additional, Zhu, Y., additional, Okpara, C.E., additional, Pinheiro, C., additional, Swaby, R.F., additional, Machiels, J-P., additional, and Tahara, M., additional

Published
2020
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44. Abstract IA20: Radiotherapy plus cetuximab or cisplatin in human papilloma-virus positive oropharyngeal cancer (NRG 1016): A randomized multicenter noninferiority trial*

Author

Ridge, J.A., primary, Ringash, J., additional, Yao, M., additional, Blakaj, D.M., additional, Razaq, M.A., additional, Colevas, A.D., additional, Beitler, J.J., additional, Jones, C.U., additional, Dunlap, N.E., additional, Seaward, S.A., additional, Spencer, S., additional, Galloway, T.J., additional, Dignam, J.J., additional, Le, Q.T., additional, Gillison, M.L., additional, Sturgis, E.M., additional, Phan, J., additional, Trotti, A.M., additional, Harris, J., additional, Eisbruch, A., additional, Harari, P.M., additional, Adelstein, D.J., additional, Koyfman, S.A., additional, and Burtness, B., additional

Published
2020
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45. Devising novel imaging biomarkers for Human Papillomavirus (HPV) status in oropharyngeal squamous cell carcinoma (OPSCC): applying radiomics and machine learning algorithms

Author

Haider, Stefan Philipp, additional, Mahajan, A, additional, Zeevi, T, additional, Forghani, R, additional, Kann, B, additional, Judson, BL., additional, Burtness, B, additional, Sharaf, K, additional, Reichel, C, additional, Baumeister, P, additional, and Payabvash, S, additional

Published
2020
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46. Entwicklung bildbasierter Radiomics-Biomarker für den Humanen Papillomavirus (HPV)-Status beim oropharyngealen Plattenepithelkarzinom (OPSCC) mittels Machine-Learning-Algorithmen

Author

Haider, SP, additional, Mahajan, A, additional, Zeevi, T, additional, Forghani, R, additional, Kann, B, additional, Judson, BL, additional, Burtness, B, additional, Sharaf, K, additional, Reichel, C, additional, Baumeister, P, additional, and Payabvash, S, additional

Published
2020
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48. Long-term outcomes from KEYNOTE-048: Pembrolizumab (pembro) alone or with chemotherapy (pembro plus C) vs EXTREME (E) as first-line (1L) therapy for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)

Author

Greil, R. Rischin, D. Harrington, K. J. Soulieres, D. and Tahara, M. de Castro, G. Psyrri, A. Baste, N. Neupane, P. Bratland, A. Fuereder, T. Hughes, B. G. M. Mesia, Sr., R. Ngamphaiboon, N. Rordorf, T. Ishak, W. Z. Wan and Lin, J. Swaby, R. F. Gumuscu, B. Burtness, B.

Published
2020

50. Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412

Author

Machiels, J-P, Tao, Y, Burtness, B, Tahara, M, Licitra, L, Rischin, D, Waldron, J, Simon, C, Gregoire, V, Harrington, K, Alves, GV, Lima, IPF, Pointreau, Y, Hughes, BGM, Aksoy, S, Hetnal, M, Ge, JY, Brown, H, Cheng, J, Bidadi, B, Siu, LL, Machiels, J-P, Tao, Y, Burtness, B, Tahara, M, Licitra, L, Rischin, D, Waldron, J, Simon, C, Gregoire, V, Harrington, K, Alves, GV, Lima, IPF, Pointreau, Y, Hughes, BGM, Aksoy, S, Hetnal, M, Ge, JY, Brown, H, Cheng, J, Bidadi, B, and Siu, LL

Abstract

Current treatment guidelines for patients with locally advanced head and neck squamous cell carcinoma (HNSCC) recommend multimodal treatment, including chemoradiation therapy (CRT) or surgery followed by radiation, with or without chemotherapy. The immune checkpoint inhibitor pembrolizumab has previously demonstrated antitumor activity in recurrent and/or metastatic HNSCC in large Phase III trials. For patients with locally advanced disease, Phase Ib data on the use of pembrolizumab in combination with chemoradiation have shown the approach to be safe and feasible. We describe here the design and rationale for KEYNOTE-412, a randomized, double-blind, Phase III trial investigating pembrolizumab or placebo administered concurrently with CRT and as maintenance treatment in patients with locally advanced HNSCC.

Published
2020

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