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1. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up

Author

Rugo, HS, Finn, RS, Diéras, V, Ettl, J, Lipatov, O, Joy, AA, Harbeck, N, Castrellon, A, Iyer, S, Lu, DR, Mori, A, Gauthier, ER, Bartlett, C Huang, Gelmon, KA, and Slamon, DJ

Subjects
Clinical Research, Estrogen, Breast Cancer, Cancer, Clinical Trials and Supportive Activities, Aging, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Double-Blind Method, Female, Humans, Letrozole, Piperazines, Postmenopause, Pyridines, Quality of Life, Receptor, ErbB-2, Receptors, Estrogen, Treatment Outcome, Breast cancer, ER, HER2-, Cyclin-dependent kinase inhibitor, Palbociclib, Receptor, erbB-2, ER+, HER2−, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeIn the initial PALOMA-2 (NCT01740427) analysis with median follow-up of 23 months, palbociclib plus letrozole significantly prolonged progression-free survival (PFS) in women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) [hazard ratio (HR) 0.58; P

Published
2019

3. The use of ribociclib in real clinical practice: results of a single-center observational retrospective study

Author

Sultanbaev, A. V., primary, Kolyadina, I. V., additional, Musin, Sh. I., additional, Nasretdinov, A. F., additional, Sultanbaeva, N. I., additional, Menshikov, K. V., additional, Menshikova, I. A., additional, Askarov, V. E., additional, Rakhimov, R. R., additional, Lipatov, D. O., additional, Lipatov, O. N., additional, Sultanbaev, M. V., additional, Zabelin, V. M., additional, Izmailov, A. A., additional, and Ayupov, R. T., additional

Published
2024
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5. Breast cancer screening in germline mutation carriers. A literature review

Author

Sultanbaev, A. V., primary, Nasretdinov, A. F., additional, Galeev, M. G., additional, Menshikov, K. V., additional, Musin, Sh. I., additional, Sultanbaeva, N. I., additional, Ayupov, R. T., additional, Rakhimov, R. R., additional, Lipatov, O. N., additional, Izmaylov, A. A., additional, Menshikova, I. A., additional, Serebrennikov, G. A., additional, and Lipatov, D. O., additional

Published
2023
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6. Sunitinib in the treatment of advanced renal cell carcinoma

Author

Sultanbaev, A. V., primary, Nasretdinov, A. F., additional, Menshikov, K. V., additional, Menshikova, I. A., additional, Sultanbaeva, N. I., additional, Musin, Sh. I., additional, Serebrennikov, G. A., additional, Izmailov, A. A., additional, and Lipatov, O. N., additional

Published
2023
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7. Ribociclib plus Endocrine Therapy in Early Breast Cancer.

Author

Slamon, D., Lipatov, O., Nowecki, Z., McAndrew, N., Kukielka-Budny, B., Stroyakovskiy, D., Yardley, D. A., Huang, C.-S., Fasching, P. A., Crown, J., Bardia, A., Chia, S., Im, S.-A., Ruiz-Borrego, M., Loi, S., Xu, B., Hurvitz, S., Barrios, C., Untch, M., and Moroose, R.

Abstract

BACKGROUND Ribociclib has been shown to have a significant overall survival benefit in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether this benefit in advanced breast cancer extends to early breast cancer is unclear. METHODS In this international, open-label, randomized, phase 3 trial, we randomly assigned patients with HR-positive, HER2-negative early breast cancer in a 1:1 ratio to receive ribociclib (at a dose of 400 mg per day for 3 weeks, followed by 1 week off, for 3 years) plus a nonsteroidal aromatase inhibitor (NSAI; letrozole at a dose of 2.5 mg per day or anastrozole at a dose of 1 mg per day for ≥5 years) or an NSAI alone. Premenopausal women and men also received goserelin every 28 days. Eligible patients had anatomical stage II or III breast cancer. Here we report the results of a prespecified interim analysis of invasive disease-free survival, the primary end point; other efficacy and safety results are also reported. Invasive disease-free survival was evaluated with the use of the Kaplan-Meier method. The statistical comparison was made with the use of a stratified log-rank test, with a protocol-specified stopping boundary of a one-sided P-value threshold of 0.0128 for superior efficacy. RESULTS As of the data-cutoff date for this prespecified interim analysis (January 11, 2023), a total of 426 patients had had invasive disease, recurrence, or death. A significant invasive disease-free survival benefit was seen with ribociclib plus an NSAI as compared with an NSAI alone. At 3 years, invasive disease-free survival was 90.4% with ribociclib plus an NSAI and 87.1% with an NSAI alone (hazard ratio for invasive disease, recurrence, or death, 0.75; 95% confidence interval, 0.62 to 0.91; P=0.003). Secondary end points -- distant disease-free survival and recurrence-free survival -- also favored ribociclib plus an NSAI. The 3-year regimen of ribociclib at a 400-mg starting dose plus an NSAI was not associated with any new safety signals. CONCLUSIONS Ribociclib plus an NSAI significantly improved invasive disease-free survival among patients with HR-positive, HER2-negative stage II or III early breast cancer. (Funded by Novartis; NATALEE ClinicalTrials.gov number, NCT03701334.) [ABSTRACT FROM AUTHOR]

Published
2024
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8. 190MO Association of 18-Gene expression profile (GEP) with clinical outcomes in patients with metastatic triple-negative breast cancer (mTNBC) treated with pembrolizumab (Pembro) or chemotherapy (Chemo) in KEYNOTE-119

Author

Cortés, J., primary, Lipatov, O., additional, Im, S-A., additional, Gonçalves, A., additional, Lee, K.S., additional, Schmid, P., additional, Tamura, K., additional, Testa, L., additional, Ohtani, S., additional, Harbeck, N., additional, Loi, S., additional, Salgado, R.F., additional, Lunceford, J., additional, Karantza, V., additional, Mejia, J.A., additional, Cristescu, R., additional, Nebozhyn, M., additional, Jelinic, P., additional, Huang, L., additional, and Winer, E.P., additional

Published
2023
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9. 191MO KEYNOTE-355: Outcomes in patients who discontinued chemotherapy before pembrolizumab and in patients with immune-mediated AEs

Author

Rugo, H.S., primary, Cescon, D.W., additional, Im, S-A., additional, Yusof, M. Md, additional, Araneda, C.E. Gallardo, additional, Lipatov, O., additional, Cruz, F., additional, Barrios, C.H., additional, Hegg, R., additional, Martín, E. Holgado, additional, Torregroza Otero, M.A., additional, Turner, N., additional, Árkosy, P.F., additional, Tarnawski, R., additional, Karantza, V., additional, Pan, W., additional, Guo, Z., additional, and Cortés, J., additional

Published
2023
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14. Territorial features of the occurrence of mutations in repair genes in patients with prostate cancer in the Republic of Bashkortostan

Author

Sultanbaev, A., primary, Nasretdinov, A., additional, Menshikov, K., additional, Musin, S., additional, Lipatov, O., additional, Izmailov, A., additional, Ayupov, R., additional, Rakhimov, R., additional, Serebrennikov, G., additional, Menshikova, I., additional, Sultanbaeva, N., additional, Lipatov, D., additional, and Popova, E., additional

Published
2022
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15. 164O Health-related quality of life (HRQoL) with pembrolizumab (pembro) + chemotherapy (chemo) vs placebo (pbo) + chemo as 1L treatment for advanced triple-negative breast cancer (TNBC): Results from KEYNOTE-355

Author

Cescon, D.W., primary, Schmid, P., additional, Rugo, H.S., additional, Im, S-A., additional, Md Yusof, M., additional, Gallardo, C.E., additional, Lipatov, O., additional, Barrios, C.H., additional, Perez Garcia, J.M., additional, Iwata, H., additional, Masuda, N., additional, Torregroza Otero, M.A., additional, Gokmen, E., additional, Loi, S., additional, Haiderali, A., additional, Zhou, X., additional, Guo, Z., additional, Martin Nguyen, A., additional, and Cortés, J., additional

Published
2022
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17. Efficacy of HD201 vs Referent Trastuzumab in Patients With ERBB2-Positive Breast Cancer Treated in the Neoadjuvant Setting

Author

Pivot, Xavier, primary, Georgievich, M. A., additional, Shamrai, Volodymyr, additional, Dzagnidze, Giorgi, additional, Soo Hoo, Hwoei Fen, additional, Kaewkangsadan, Viriya, additional, Petrelli, Fausto, additional, Villanueva, Cristian, additional, Nikolaevich, Lipatov O., additional, Hii, Jocelyn, additional, Kim, Jamie, additional, Pradhan, Sumita, additional, Jaison, Litha, additional, Feyaerts, Peggy, additional, Kaufman, Leonard, additional, Derde, Marie-Paule, additional, Bonamy, Ghislain M. C., additional, Deforce, Filip, additional, and Cox, David G., additional

Published
2022
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19. Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma†

Author

Al-Batran, S.-E., Van Cutsem, E., Oh, S. C., Bodoky, G., Shimada, Y., Hironaka, S., Sugimoto, N., Lipatov, O. N., Kim, T.-Y., Cunningham, D., Rougier, P., Muro, K., Liepa, A. M., Chandrawansa, K., Emig, M., Ohtsu, A., and Wilke, H.

Published
2016
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21. LBA16 KEYNOTE-355: Final results from a randomized, double-blind phase III study of first-line pembrolizumab + chemotherapy vs placebo + chemotherapy for metastatic TNBC

Author

Cortés, J., primary, Cescon, D.W., additional, Rugo, H.S., additional, Im, S-A., additional, Md Yusof, M., additional, Gallardo, C., additional, Lipatov, O., additional, Barrios, C.H., additional, Perez-Garcia, J., additional, Iwata, H., additional, Masuda, N., additional, Torregroza Otero, M., additional, Gokmen, E., additional, Loi, S., additional, Guo, Z., additional, Zhou, X., additional, Karantza, V., additional, Pan, W., additional, and Schmid, P., additional

Published
2021
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22. Sequential anticancer therapy in a patient with metachronous primary uterine cancer and breast cancer

Author

Sultanbaev, A.  V., primary, Nasretdinov, A.  F., additional, Sultanbaeva, N.  I., additional, Menshikov, K.  V., additional, Musin, Sh.  I., additional, Izmailov, A.  A., additional, Lipatov, O.  N., additional, Pushkarev, V.  A., additional, Valiakhmedov, R.  B., additional, Pushkarev, A.  V., additional, and Mufazalov, F.  F., additional

Published
2021
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23. KEYNOTE-355: Final results from a randomized, double-blind phase III study of first-line pembrolizumab plus chemotherapy vs placebo plus chemotherapy for metastatic TNBC

Author

Cortes, J., Cescon, D. W., Rugo, H. S., Im, S-A., Yusof, M. Md, Gallardo, C., and Lipatov, O.

Abstract

Congress of the European-Society-for-Medical-Oncology (ESMO) -- SEP 16-21, 2021 -- ELECTR NETWORK, [No Abstract Available], European Soc Med Oncol,Japanese Soc Med Oncol, Merck Sharp Dohme Corp., Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Published
2021

24. KEYNOTE-355: Final results from a randomized, doubleblind phase III study of first-line pembrolizumab + chemotherapy vs placebo + chemotherapy for metastatic TNBC

Author

Cortés Castán, Javier, Cescon, D. W., Rugo, H. S., Im, S. A., Yuso, M. Md., Gallardo, C., Lipatov, O., Barrios, C. H., Pérez García, José Manuel, and Schmid, P.

Subjects
Placebos, Tratamiento médico, Efectos fisiológicos, Neoplasias de la mama triple negativas, Quimioterapia, Cáncer
Abstract

Sin financiación 51.769 JCR (2021) Q1, 5/245 Oncology 8.590 SJR (2021) Q1, 2/133 Hematology No data IDR 2020 UEM

Published
2021

25. LBA23 Invasive disease–free survival (iDFS) across key subgroups from the phase III NATALEE study of ribociclib (RIB) + a nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2- early breast cancer (EBC)

Author

Bardia, A., Hortobagyi, G.N., Lipatov, O., McAndrew, N.P., Lacko, A., Sohn, J., Hart, L., Crown, J.P., Im, S-A., Harbeck, N., O'Shaughnessy, J., Xu, B., Barrios, C.H., Moroose, R., Gonzalez, V., Fresco, R., Ghaznawi, F., Waters, S., Chakravartty, A., and Slamon, D.

Published
2023
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26. Efficacy of HD201 vs Referent Trastuzumab in Patients With ERBB2-Positive Breast Cancer Treated in the Neoadjuvant Setting

Author

Xavier, Pivot, M A, Georgievich, Volodymyr, Shamrai, Giorgi, Dzagnidze, Hwoei Fen, Soo Hoo, Viriya, Kaewkangsadan, Fausto, Petrelli, Cristian, Villanueva, Lipatov O, Nikolaevich, Jocelyn, Hii, Jamie, Kim, Sumita, Pradhan, Litha, Jaison, Peggy, Feyaerts, Leonard, Kaufman, Marie-Paule, Derde, Ghislain M C, Bonamy, Filip, Deforce, and David G, Cox

Subjects
Adult, Aged, 80 and over, Cancer Research, Receptor, ErbB-2, Correction, Antineoplastic Agents, Breast Neoplasms, Middle Aged, Trastuzumab, Neoadjuvant Therapy, Oncology, Humans, Female, Aged
Abstract

The drug HD201 is a biosimilar candidate for breast cancer treatment as the reference trastuzumab.To compare the efficacy of HD201 with referent trastuzumab.This randomized clinical trial (TROIKA) included 502 women with ERBB2-positive early breast cancer treated with either HD201 or referent trastuzumab. It was conducted across 70 centers in 12 countries, including Western and Eastern Europe and Asian countries. Randomization was stratified by tumor hormone receptor status, clinical stage, and geographic region of recruitment. This analysis was conducted on February 12, 2021, after the completion of the adjuvant phase at a median of 31 months (IQR, 28-33 months) of follow-up.Patients with ERBB2-positive early breast cancer were randomly assigned to receive HD201 or referent trastuzumab in the neoadjuvant setting for 8 cycles, concurrently with 4 cycles of docetaxel, which was followed by 4 cycles of epirubicin and cyclophosphamide. Patients then underwent surgery, which was followed by treatment with 10 cycles of adjuvant HD201 or referent trastuzumab.The primary end point was the total pathological complete response (tpCR) assessed after neoadjuvant treatment. Equivalence was concluded if the 95% CI of the absolute difference in tpCR between arms in the per-protocol set was within the margin of more or less than 15%. Other objectives included the breast pathological complete response, overall response, event-free and overall survival, safety, pharmacokinetics, and immunogenicity.A total of 502 female patients (mean [range] age, 53 [26-82] years) were randomized to receive either HD201 or referent trastuzumab, and 474 (94.2%) were eligible for inclusion in the per-protocol set. The baseline characteristics were well balanced between the 2 arms; 195 tumors (38.8%) were hormone receptor-negative , and 213 patients (42.4%) had clinical stage III disease. The tpCR rates were 45% and 48.7% for HD201 and referent trastuzumab, respectively. The difference between the 2 groups was not significant at -3.8% (95% CI, -12.8% to 5.4%) and fell within the predefined equivalence margins. The ratio of the tpCR rates between the 2 arms was 0.92 (95% CI, 0.76 to 1.12). A total of 433 patients (86.1%) presented with 2232 treatment-emergent adverse events of special interest for trastuzumab during the entire treatment period, with 220 (88.0%) and 213 (84.5%) patients in the HD201 and referent trastuzumab groups, respectively.The results of this randomized clinical trial found that HD201 demonstrated equivalence to referent trastuzumab in terms of efficacy for the end point of tpCR, with a similar safety profile.ClinicalTrials.gov Identifier: NCT03013504.

Published
2022
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27. Multilineal treatment strategy of HER2-positive metastatic breast cancer (clinical case)

Author

Nasretdinov, A.   F., primary, Pushkarev, A.   V., additional, Lipatov, O.  N., additional, Sultanbaeva, N.   I., additional, Musin, Sh.   I., additional, Menshikov, K.   V., additional, Izmailov, A.   A., additional, Pushkarev, V.   A., additional, Galeev, M.   G., additional, Muginov, R.   R., additional, Valiakhmedov, R.   B., additional, Sakaeva, D.   D., additional, and Sultanbaev, A.   V., additional

Published
2021
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28. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial

Author

Powles, T. van der Heijden, M.S. Castellano, D. Galsky, M.D. Loriot, Y. Petrylak, D.P. Ogawa, O. Park, S.H. Lee, J.-L. De Giorgi, U. Bögemann, M. Bamias, A. Eigl, B.J. Gurney, H. Mukherjee, S.D. Fradet, Y. Skoneczna, I. Tsiatas, M. Novikov, A. Suárez, C. Fay, A.P. Duran, I. Necchi, A. Wildsmith, S. He, P. Angra, N. Gupta, A.K. Levin, W. Bellmunt, J. van der Heijden, M.S. Lee, J.L. Eigl, B.J. Mukherjee, S.D. Suarez, C. Westgeest, H. Flechon, A. Ou, Y.-C. Park, I. Matveev, V. Pérez-Valderrama, B. Cheng, S. Frank, S. Anido, U. Hamzaj, A. Retz, M. Sridhar, S. Scagliotti, G.V. Voortman, J. Alekseev, B. Alyasova, A. Komyakov, B. Dumez, H. Pavic, M. Kimura, G. Mizokami, A. Osanto, S. Arranz, J.A. Piersma, D. Shin, S.J. Karyakin, O. Delgado, I. Gonzalez, J.L. Pang, S.-T. Tran, A. Lipatov, O. Su, W.-P. Flaig, T. Alva, A. Park Kyong, H. Kopyltsov, E. Almagro, E. Domenech, M. Chang, Y.-H. Sautois, B. Ravaux, A. Aravantinos, G. Georgoulias, V. Mulder, S. Kim, Y.J. Kater, F. Chevreau, C. Tagawa, S. Zalewski, P. Joly, F. Hatiboglu, G. Gianni, L. Morelli, F. Tambaro, R. Hashimoto, Y. Nosov, A. Font, A. Rodriguez-Vida, A.M. Jones, R. Vasudev, N. Srinivas, S. Zhang, J. Gil, T. Finch, D. Grimm, M.-O. Su, Y.-L. Chowdhury, S. Hocking, C. Plas, E. North, S. Jensen, N.V. Theodore, C. Imkamp, F. Peer, A. Kobayashi, T. Sakai, H. Sassa, N. Yoshimura, K. Aarts, M. Ferreira Castro, A. Topuzov, M. Rodriguez, J.F. Vazquez, F.J. Tsai, Y.-C. Crabb, S. Hussain, S. Bendell, J. Gross-Goupil, M. Gwenaelle, G. Berger, R. Statsenko, G. Evans, L. Drakaki, A. Somer, B. Davis, I. Lynam, J. Borges, G. Dettino, A. Fay, A.P. Martins, G. Zucca, L.E. Agerbaek, M. Kalofonos, H. Rosenbaum, E. Enokida, H. Kikukawa, H. Nishimura, K. Tamada, S. Uemura, M. Lopez, Y. Gietema, J. Slojewski, M. Fernandes, I. Smolin, A. Mazhar, D. Kalebasty, A.R. Carthon, B. Loidl, W. Franke, F. Girotto, G. Alimohamed, N. Macfarlane, R. Pappot, H. Niegisch, G. Mavroudis, D. Sella, A. Porta, C. Ebara, S. Nakamura, M. Obara, W. Okuno, N. Shinohara, N. Sugimoto, M. Suzuki, A. Tokuda, N. Uemura, H. Yamaguchi, A. Ramirez, F. Rozanowski, P. Wiechno, P. Keam, B. Kislov, N. Plaksin, D. Cicin, I. Kumar, S. Galsky, M.D. Petrylak, D.P. Rosales, J. Vaishampayan, U. Culine, S. Papandreou, C. Nara, T. Erman, M. Kreiger, L. Janoski, J. Rosa, D. Siqueira, M. Canil, C. Sengelov, L. Tourani, J.-M. Arai, G. Hashine, K. Kawakita, M. Nakaigawa, N. Nomi, H. Shiina, H. Suzuki, H. Yonese, J. Kuri, R. Macedo, E. Rivera, S. Villalobos Prieto, A. Polakiewicz-Gilowska, A. Zaucha, R. Lopes, F. Ponomarev, R. Pomerantz, M. Shariat, S. Luk, C. Lesniewski-Kmak, K.

Abstract

Background: Survival outcomes are poor for patients with metastatic urothelial carcinoma who receive standard, first-line, platinum-based chemotherapy. We assessed the overall survival of patients who received durvalumab (a PD-L1 inhibitor), with or without tremelimumab (a CTLA-4 inhibitor), as a first-line treatment for metastatic urothelial carcinoma. Methods: DANUBE is an open-label, randomised, controlled, phase 3 trial in patients with untreated, unresectable, locally advanced or metastatic urothelial carcinoma, conducted at 224 academic research centres, hospitals, and oncology clinics in 23 countries. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0 or 1. We randomly assigned patients (1:1:1) to receive durvalumab monotherapy (1500 mg) administered intravenously every 4 weeks; durvalumab (1500 mg) plus tremelimumab (75 mg) administered intravenously every 4 weeks for up to four doses, followed by durvalumab maintenance (1500 mg) every 4 weeks; or standard-of-care chemotherapy (gemcitabine plus cisplatin or gemcitabine plus carboplatin, depending on cisplatin eligibility) administered intravenously for up to six cycles. Randomisation was done through an interactive voice–web response system, with stratification by cisplatin eligibility, PD-L1 status, and presence or absence of liver metastases, lung metastases, or both. The coprimary endpoints were overall survival compared between the durvalumab monotherapy versus chemotherapy groups in the population of patients with high PD-L1 expression (the high PD-L1 population) and between the durvalumab plus tremelimumab versus chemotherapy groups in the intention-to-treat population (all randomly assigned patients). The study has completed enrolment and the final analysis of overall survival is reported. The trial is registered with ClinicalTrials.gov, NCT02516241, and the EU Clinical Trials Register, EudraCT number 2015-001633-24. Findings: Between Nov 24, 2015, and March 21, 2017, we randomly assigned 1032 patients to receive durvalumab (n=346), durvalumab plus tremelimumab (n=342), or chemotherapy (n=344). At data cutoff (Jan 27, 2020), median follow-up for survival was 41·2 months (IQR 37·9–43·2) for all patients. In the high PD-L1 population, median overall survival was 14·4 months (95% CI 10·4–17·3) in the durvalumab monotherapy group (n=209) versus 12·1 months (10·4–15·0) in the chemotherapy group (n=207; hazard ratio 0·89, 95% CI 0·71–1·11; p=0·30). In the intention-to-treat population, median overall survival was 15·1 months (13·1–18·0) in the durvalumab plus tremelimumab group versus 12·1 months (10·9–14·0) in the chemotherapy group (0·85, 95% CI 0·72–1·02; p=0·075). In the safety population, grade 3 or 4 treatment-related adverse events occurred in 47 (14%) of 345 patients in the durvalumab group, 93 (27%) of 340 patients in the durvalumab plus tremelimumab group, and in 188 (60%) of 313 patients in the chemotherapy group. The most common grade 3 or 4 treatment-related adverse event was increased lipase in the durvalumab group (seven [2%] of 345 patients) and in the durvalumab plus tremelimumab group (16 [5%] of 340 patients), and neutropenia in the chemotherapy group (66 [21%] of 313 patients). Serious treatment-related adverse events occurred in 30 (9%) of 345 patients in the durvalumab group, 78 (23%) of 340 patients in the durvalumab plus tremelimumab group, and 50 (16%) of 313 patients in the chemotherapy group. Deaths due to study drug toxicity were reported in two (1%) patients in the durvalumab group (acute hepatic failure and hepatitis), two (1%) patients in the durvalumab plus tremelimumab group (septic shock and pneumonitis), and one (

Published
2020

29. Phase III KEYNOTE-355 study of pembrolizumab (pembro) vs placebo (pbo) plus chemotherapy (chemo) for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC): Results for patients (Pts) enrolled in Asia

Author

Yusof, M. Md, Cescon, D. W., Rugo, H. S., Im, S-A., Gallardo, C., Lipatov, O., Gokmen, E., and Ege Üniversitesi

Subjects
[No Keyword]
Abstract

[No Abstract Available], European Soc Med Oncol, Merck Sharp Dohme Corp.Merck & Company, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Published
2020

35. 44O Pembrolizumab (pembro) vs chemotherapy (chemo) for previously treated metastatic triple-negative breast cancer (mTNBC): KEYNOTE-119 Asia-Pacific subpopulation

Author

Im, S-A., primary, Cortes, J., additional, Lipatov, O., additional, Goncalves, A., additional, Lee, K-S., additional, Schmid, P., additional, Tamura, K., additional, Testa, L., additional, Witzel, I., additional, Ohtani, S., additional, Zambelli, S., additional, Harbeck, N., additional, Andre, F., additional, Dent, R., additional, Lin, J., additional, Karantza, V., additional, Mejia, J.A., additional, and Winer, E.P., additional

Published
2020
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36. 43O Phase III KEYNOTE-355 study of pembrolizumab (pembro) vs placebo (pbo) + chemotherapy (chemo) for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC): Results for patients (Pts) enrolled in Asia

Author

Yusof, M. Md, primary, Cescon, D.W., additional, Rugo, H.S., additional, Im, S-A., additional, Gallardo, C., additional, Lipatov, O., additional, Barrios, C.H., additional, Holgado, E., additional, Iwata, H., additional, Masuda, N., additional, Gokmen, E., additional, Loi, S., additional, Guo, Z., additional, Jensen, E., additional, Aktan, G., additional, Karantza, V., additional, Schmid, P., additional, and Cortes, J., additional

Published
2020
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43. KEYNOTE-119: Phase III study of pembrolizumab (pembro) versus single-agent chemotherapy (chemo) for metastatic triple negative breast cancer (mTNBC)

Author

Cortés, J., primary, Lipatov, O., additional, Im, S.-A., additional, Gonçalves, A., additional, Lee, K.S., additional, Schmid, P., additional, Tamura, K., additional, Testa, L., additional, Witzel, I., additional, Ohtani, S., additional, Zambelli, S., additional, Harbeck, N., additional, André, F., additional, Dent, R., additional, Zhou, X., additional, Karantza, V., additional, Mejia, J.A., additional, and Winer, E.P., additional

Published
2019
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47. Abstract P5-21-03: Palbociclib (PAL) + letrozole (LET) as first-line therapy in estrogen receptor–positive (ER+)/human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer (ABC): Efficacy and safety updates with longer follow-up across patient subgroups

Author

Rugo, HS, primary, Finn, RS, additional, Dieras, V, additional, Ettl, J, additional, Lipatov, O, additional, Joy, A, additional, Harbeck, N, additional, Castrellon, A, additional, Lu, DR, additional, Mori, A, additional, Gauthier, ER, additional, Huang, C, additional, Gelmon, KA, additional, and Slamon, DJ, additional

Published
2018
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49. Abstract P1-10-01: A randomized, double-blind trial to compare the efficacy and safety of proposed biosimilar pegfilgrastim (LA-EP2006) with reference pegfilgrastim in patients with breast cancer (PROTECT1)

Author

Harbeck, N, primary, Zbarskaya, I, additional, Lipatov, O, additional, Frolova, M, additional, Udovitsa, D, additional, Topuzov, E, additional, Ganea-Motan, DE, additional, Nakov, R, additional, Singh, P, additional, Rudy, A, additional, and Blackwell, K, additional

Published
2016
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50. Abstract P6-14-03: Genome wide association study (GWAS) to identify variants conferring ramucirumab-associated hypertension in the ROSE/TRIO-012 breast cancer trial

Author

Mackey, JR, primary, Lipatov, O, additional, Martín, M, additional, Webster, M, additional, Hegg, R, additional, Verma, S, additional, Ramos-Vázquez, M, additional, Fresco, R, additional, Thireau, F, additional, Houé, V, additional, Press, MF, additional, Kumaran, M, additional, and Damaraju, S, additional

Published
2016
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