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1. Re-administration of platinum-based chemotherapy for recurrent endometrial cancer: an ancillary analysis of the SGSG-012/GOTIC-004/Intergroup study

Author

Nagao, Shoji, Nishio, Shin, Takehara, Kazuhiro, Sato, Shinya, Satoh, Toyomi, Shimada, Muneaki, Yamaguchi, Satoshi, Tanabe, Hiroshi, Takano, Masashi, Horie, Kouji, Takei, Yuji, Imai, Yuichi, Hibino, Yumi, Hasegawa, Kosei, Takekuma, Munetaka, Nakamura, Kazuto, Takano, Hirokuni, Fujiwara, Keiichi, and Masuyama, Hisashi

Published
2024
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3. Atezolizumab and chemotherapy for advanced or recurrent endometrial cancer (AtTEnd): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Zola, Paolo, Casanova, Claudia, Arcangeli, Valentina, Antonuzzo, Lorenzo, Gadducci, Angiolo, Cosio, Stefania, Clamp, Andrew, Persic, Mojca, McNeish, Ian, Tookman, Laura, Redondo Sanchez, Andrés, Choi, Chel Hun, Baldini, Editta, Palaia, Innocenza, Benedetti Panici, Pierluigi, Takahashi, Nobutaka, Lombard, Janine, Ardizzoia, Antonio, Bologna, Alessandra, Herrero Ibáñez, Ana Maria, Musolino, Antonino, Márquez Vázquez, Raúl, Pietzner, Klaus, Braicu, Elena, Heinzelmann-Schwarz, Viola A., Powell, Melanie, Yokoyama, Yoshihito, Baron-Hay, Sally, Abeni, Chiara, Martin Lorente, Cristina, Cueva, Juan Fernando, Trillsch, Fabian, Heitz, Florian, Ataseven, Beyhan, Petru, Edgar, Heubner, MartinLeonhard, Sadozye, Azmat Hassanq, Dubey, Sidharth, Tazbirkova, Andrea, Tiley, Susan, Chrystal, Kathryn, Kim, Sang Wun, Fehr, Mathias, Scatchard, Kate, Anand, Anjana, Taylor, Alexandra, Watary, Hidemichi, Enomoto, Takayuki, Yoshihara, Kosuke, Selva-Nayagam, Sudarsha, Karki, Bhaskar, Harrison, Michelle, Wilkinson, Kate, Goh, Jeffrey, Glasgow, Amanda, Chantrill, Lorraine, Lee, Chulmin, Bertolini, Alessandro, Narducci, Filomena, Bellotti, Giovanna, Fusco, Vittorio, Aebi, Stefan, Del Grande, Maria, Colombo, Ilaria, Tokunaga, Hideki, Shigeta, Shogo, Goss, Geraldine, Siow, Zhen Rong, Steer, Christopher, Lin, Hao, Lee, Kwang-Beom, Di Meglio, Giovanni, Massa, Elena, De Marino, Elvira, Tortora, Vincenzo, Palacio Vazquez, Isabel, Tsuji, Kosuke, Tominaga, Eiichiro, Black, Allison, So, Kyeong A, Suh, Dong Hoon, Lee, Keun Ho, Kim, Yong Man, Fossati, Roldano, Carlucci, Luciano, Barberis, Massimo, Torri, Valter, Santoni, Anna, Colombo, Nicoletta, Biagioli, Elena, Harano, Kenichi, Galli, Francesca, Hudson, Emma, Antill, Yoland, Rabaglio, Manuela, Marmé, Frederic, Marth, Christian, Parma, Gabriella, Fariñas-Madrid, Lorena, Nishio, Shin, Allan, Karen, Lee, Yeh Chen, Piovano, Elisa, Pardo, Beatriz, Nakagawa, Satoshi, McQueen, John, Zamagni, Claudio, Manso, Luis, Takehara, Kazuhiro, Tasca, Giulia, Ferrero, Annamaria, Tognon, Germana, Lissoni, Andrea Alberto, Petrella, Mariacristina, Laudani, Maria Elena, Rulli, Eliana, Uggeri, Sara, and Barretina Ginesta, M Pilar

Published
2024
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6. Clinical characteristics and prognostic factors of endometrial stromal sarcoma and undifferentiated uterine sarcoma confirmed by central pathologic review: A multi-institutional retrospective study from the Japanese Clinical Oncology Group

Author

Kikuchi, Akira, Yoshida, Hiroshi, Tsuda, Hitoshi, Nishio, Shin, Suzuki, Shiro, Takehara, Kazuhiro, Kino, Nao, Sumi, Toshiyuki, Kato, Kazuyoshi, Yokoyama, Masatoshi, Nakamura, Kazuto, Takano, Masashi, Sato, Shinya, Kato, Hisamori, Tamate, Masato, Horie, Koji, Kato, Tomoyasu, Sakamoto, Atsuhiko, Fukunaga, Masaharu, Kaku, Tsunehisa, Yoshida, Masayuki, Yaegashi, Nobuo, and Satoh, Toyomi

Published
2023
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9. Cemiplimab monotherapy in Japanese patients with recurrent or metastatic cervical cancer.

Author

Hasegawa, Kosei, Takahashi, Shunji, Ushijima, Kimio, Okadome, Masao, Yonemori, Kan, Yokota, Harushige, Vergote, Ignace, Monk, Bradley J., Tewari, Krishnansu S., Fujiwara, Keiichi, Li, Jingjin, Jamil, Shaheda, Paccaly, Anne, Takehara, Kazuhiro, Usami, Tomoka, Aoki, Yoichi, Suzuki, Nao, Kobayashi, Yoichi, Yoshida, Yoshio, and Watari, Hidemichi

Subjects
CANCER chemotherapy, JAPANESE people, CEMIPLIMAB, CERVICAL cancer, OVERALL survival
Abstract

Background: In the phase 3 EMPOWER‐Cervical 1/GOG‐3016/ENGOT‐cx9 study, cemiplimab significantly improved overall survival (OS) versus chemotherapy for patients with recurrent or metastatic cervical cancer who progressed after first‐line platinum‐based chemotherapy. We present a post hoc subgroup analysis of patients enrolled in Japan. Methods: Patients were enrolled regardless of programmed cell death‐ligand 1 status and randomized 1:1 to cemiplimab 350 mg intravenously every 3 weeks or investigator's choice single‐agent chemotherapy for up to 96 weeks. Primary endpoint was OS. Key secondary endpoints were progression‐free survival (PFS) and objective response rate (ORR). Results: Overall, 608 patients were randomized, of whom 56 (9.2%) were in Japan (cemiplimab, n = 29; chemotherapy, n = 27). The median (range) duration of follow‐up was 13.6 (6.0–25.3) versus 18.2 (6.0–38.2) months for patients in Japan and for the overall population, respectively. Median OS (95% confidence interval [CI]) was 8.4 (7.0‐not evaluable) and 9.4 (5.4–14.9) months for cemiplimab versus chemotherapy (hazard ratio [HR]: 0.86; 95% CI: 0.43–1.68). Median PFS (95% CI) was 4.0 (1.4–8.2) versus 3.7 (1.8–4.2) months with cemiplimab and chemotherapy (HR: 0.90; 95% CI: 0.50–1.61), respectively. ORR was 17.2% for cemiplimab and 7.4% for chemotherapy (odds ratio, 2.47; 95% CI, 0.44–13.99). Incidence of treatment‐emergent adverse events at any grade was 79.3% for cemiplimab and 100% for chemotherapy. Grade ≥3 adverse events were 37.9% versus 66.7% with cemiplimab and chemotherapy, respectively. Discussion: While acknowledging limitations inherent to a small subgroup analysis, the HR of 0.86 observed in Japanese patients suggests an emerging survival benefit despite a 4.6‐month shorter median duration of follow‐up versus the overall study population. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Uterine serous carcinoma

Author

Bogani, Giorgio, Ray-Coquard, Isabelle, Concin, Nicole, Ngoi, Natalie Y.L., Morice, Philippe, Enomoto, Takayuki, Takehara, Kazuhiro, Denys, Hannelore, Nout, Remi A., Lorusso, Domenica, Vaughan, Michelle M., Bini, Marta, Takano, Masashi, Provencher, Diane, Indini, Alice, Sagae, Satoru, Wimberger, Pauline, Póka, Robert, Segev, Yakir, Kim, Se Ik, Candido dos Reis, Francisco J., Lopez, Salvatore, Mariani, Andrea, Leitao, Mario M., Jr, Raspagliesi, Francesco, Panici, Pieluigi Benedetti, Di Donato, Violante, Muzii, Ludovico, Colombo, Nicoletta, Scambia, Giovanni, Pignata, Sandro, and Monk, Bradley J.

Published
2021
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12. Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial

Author

Korach, Jacob, Huzarski, Tomasz, Byrski, Tomasz, Pautier, Patricia, Friedlander, Michael, Harter, Philipp, Colombo, Nicoletta, Pignata, Sandro, Scambia, Giovanni, Nicoletto, Maria, Nussey, Fiona, Clamp, Andrew, Penson, Richard, Oza, Amit, Poveda Velasco, Andrés, Rodrigues, Manuel, Lotz, Jean-Pierre, Selle, Frédéric, Ray-Coquard, Isabelle, Provencher, Diane, Prat Aparicio, Aleix, Vidal Boixader, Laura, Scott, Clare, Tamura, Kenji, Yunokawa, Mayu, Lisyanskaya, Alla, Medioni, Jacques, Pécuchet, Nicolas, Dubot, Coraline, De La Motte Rouge, Thibault, Kaminsky, Marie-Christine, Weber, Béatrice, Lortholary, Alain, Parkinson, Christine, Ledermann, Jonathan, Williams, Sarah, Banerjee, Susana, Cosin, Jonathan, Hoffman, James, Plante, Marie, Covens, Allan, Sonke, Gabe, Joly, Florence, Floquet, Anne, Hirte, Holger, Amit, Amnon, Park-Simon, Tjoung-Won, Matsumoto, Koji, Tjulandin, Sergei, Hoon Kim, Jae, Gladieff, Laurence, Sabbatini, Roberto, O'Malley, David, Timmins, Patrick, Kredentser, Daniel, Laínez Milagro, Nuria, Barretina Ginesta, Maria Pilar, Tibau Martorell, Ariadna, Gómez De Liaño Lista, Alfonso, Ojeda González, Belén, Mileshkin, Linda, Mandai, Masaki, Boere, Ingrid, Ottevanger, Petronella, Nam, Joo-Hyun, Filho, Elias, Hamizi, Salima, Cognetti, Francesco, Warshal, David, Dickson-Michelson, Elizabeth, Kamelle, Scott, McKenzie, Nathalie, Rodriguez, Gustavo, Armstrong, Deborah, Chalas, Eva, Celano, Paul, Behbakht, Kian, Davidson, Susan, Welch, Stephen, Helpman, Limor, Fishman, Ami, Bruchim, Ilan, Sikorska, Magdalena, Słowińska, Anna, Rogowski, Wojciech, Bidziński, Mariusz, Śpiewankiewicz, Beata, Casado Herraez, Antonio, Mendiola Fernández, César, Gropp-Meier, Martina, Saito, Toshiaki, Takehara, Kazuhiro, Enomoto, Takayuki, Watari, Hidemichi, Choi, Chel Hun, Kim, Byoung-Gie, Weon Kim, Jae, Hegg, Roberto, Vergote, Ignace, Poveda, Andrés, Ledermann, Jonathan A, Asher, Rebecca, Penson, Richard T, Oza, Amit M, Baldoni, Alessandra, Sonke, Gabe S, Kim, Jae-Hoon, Filho, Elias Abdo, Milenkova, Tsveta, Lowe, Elizabeth S, Rowe, Phil, and Pujade-Lauraine, Eric

Published
2021
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18. The mesenchymal transition subtype more responsive to dose dense taxane chemotherapy combined with carboplatin than to conventional taxane and carboplatin chemotherapy in high grade serous ovarian carcinoma: A survey of Japanese Gynecologic Oncology Group study (JGOG3016A1)

Author

Murakami, Ryusuke, Matsumura, Noriomi, Michimae, Hirofumi, Tanabe, Hiroshi, Yunokawa, Mayu, Iwase, Haruko, Sasagawa, Motoi, Nakamura, Toshiaki, Tokuyama, Osamu, Takano, Masashi, Sugiyama, Toru, Sawasaki, Takashi, Isonishi, Seiji, Takehara, Kazuhiro, Nakai, Hidekatsu, Okamoto, Aikou, Mandai, Masaki, and Konishi, Ikuo

Published
2019
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19. Analysis of gastric-type mucinous carcinoma of the uterine cervix — An aggressive tumor with a poor prognosis: A multi-institutional study

Author

Nishio, Shin, Mikami, Yoshiki, Tokunaga, Hideki, Yaegashi, Nobuo, Satoh, Toyomi, Saito, Motoaki, Okamoto, Aikou, Kasamatsu, Takahiro, Miyamoto, Tsutomu, Shiozawa, Tanri, Yoshioka, Yumiko, Mandai, Masaki, Kojima, Atsumi, Takehara, Kazuhiro, Kaneki, Eisuke, Kobayashi, Hiroaki, Kaku, Tsunehisa, Ushijima, Kimio, and Kamura, Toshiharu

Published
2019
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22. Human papillomavirus vaccine impact on invasive cervical cancer in Japan: Preliminary results from cancer statistics and the MINT study.

Author

Onuki, Mamiko, Takahashi, Fumiaki, Iwata, Takashi, Nakazawa, Hiroshi, Yahata, Hideaki, Kanao, Hiroyuki, Horie, Koji, Konnai, Katsuyuki, Nio, Ai, Takehara, Kazuhiro, Kamiura, Shoji, Tsuda, Naotake, Takei, Yuji, Shigeta, Shogo, Matsumura, Noriomi, Yoshida, Hiroyuki, Motohara, Takeshi, Yamazaki, Hiroyuki, Nakamura, Keiichiro, and Hamanishi, Junzo

Abstract

The first prophylactic vaccine against human papillomavirus (HPV) 16 and HPV18 was licensed in Japan in 2009. HPV vaccine effectiveness against high‐grade cervical lesions has been demonstrated among young Japanese women, but evidence of its effects on invasive cervical cancer (ICC) is lacking. Using data from two different cancer registries, we compared recent trends of new ICC cases by age group using Poisson regression analysis. We also analyzed time trends in HPV16/18 prevalence among 1414 Japanese women aged <40 years newly diagnosed with ICC in the past decade. Based on the population‐based cancer registry, the incidence of ICC among young women aged 20–29 years showed a significant decline from 3.6 to 2.8 per 100 000 women‐years during 2016–2019, but no similar decline was observed for older age groups (p < 0.01). Similarly, using data from the gynecological cancer registry of the Japan Society of Obstetrics and Gynecology, the annual number of ICCs among women aged 20–29 years also decreased from 256 cases to 135 cases during 2011–2020 (p < 0.0001). Furthermore, a declining trend in HPV16/18 prevalence in ICC was observed only among women aged 20–29 years during 2017–2022 (90.5%–64.7%, p = 0.05; Cochran–Armitage trend test). This is the first report to suggest population‐level effects of HPV vaccination on ICC in Japan. Although the declining trend in HPV16/18 prevalence among young women with ICC supports a causal linkage between vaccination and results from cancer registries, further studies are warranted to confirm that our findings are attributable to vaccination. [ABSTRACT FROM AUTHOR]

Published
2023
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24. Comparison of treatment invasiveness between upfront debulking surgery versus interval debulking surgery following neoadjuvant chemotherapy for stage III/IV ovarian, tubal, and peritoneal cancers in a phase III randomised trial: Japan Clinical Oncology Group Study JCOG0602

Author

Onda, Takashi, Satoh, Toyomi, Saito, Toshiaki, Kasamatsu, Takahiro, Nakanishi, Toru, Nakamura, Kenichi, Wakabayashi, Masashi, Takehara, Kazuhiro, Saito, Motoaki, Ushijima, Kimio, Kobayashi, Hiroaki, Kawana, Kei, Yokota, Harushige, Takano, Masashi, Takeshima, Nobuhiro, Watanabe, Yoh, Yaegashi, Nobuo, Konishi, Ikuo, Kamura, Toshiharu, and Yoshikawa, Hiroyuki

Published
2016
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26. Clinical tumor diameter and prognosis of patients with FIGO stage IB1 cervical cancer (JCOG0806-A)

Author

Kato, Tomoyasu, Takashima, Atsuo, Kasamatsu, Takahiro, Nakamura, Kenichi, Mizusawa, Junki, Nakanishi, Toru, Takeshima, Nobuhiro, Kamiura, Shoji, Onda, Takashi, Sumi, Toshiyuki, Takano, Masashi, Nakai, Hidekatsu, Saito, Toshiaki, Fujiwara, Kiyoshi, Yokoyama, Masatoshi, Itamochi, Hiroaki, Takehara, Kazuhiro, Yokota, Harushige, Mizunoe, Tomoya, Takeda, Satoru, Sonoda, Kenzo, Shiozawa, Tanri, Kawabata, Takayo, Honma, Shigeru, Fukuda, Haruhiko, Yaegashi, Nobuo, Yoshikawa, Hiroyuki, Konishi, Ikuo, and Kamura, Toshiharu

Published
2015
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30. Trastuzumab Deruxtecan for Human Epidermal Growth Factor Receptor 2–Expressing Advanced or Recurrent Uterine Carcinosarcoma (NCCH1615): The STATICE Trial.

Author

Nishikawa, Tadaaki, Hasegawa, Kosei, Matsumoto, Koji, Mori, Masahiko, Hirashima, Yasuyuki, Takehara, Kazuhiro, Ariyoshi, Kazuya, Kato, Tomoyasu, Yagishita, Shigehiro, Hamada, Akinobu, Kawasaki, Mamiko, Kawashima, Satoshi, Tomatsuri, Sawako, Nagasaka, Yukari, Yoshida, Hiroshi, Machida, Ryunosuke, Hirakawa, Akihiro, Nakamura, Kenichi, and Yonemori, Kan

Published
2023
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31. Intraperitoneal Carboplatin for Ovarian Cancer - A Phase 2/3 Trial.

Author

Nagao, Shoji, Fujiwara, Keiichi, Yamamoto, Kouji, Tanabe, Hiroshi, Okamoto, Aikou, Takehara, Kazuhiro, Saito, Motoaki, Fujiwara, Hiroyuki, Tan, David S. P., Yamaguchi, Satoshi, Adachi, Sosuke, Kikuchi, Akira, Hirasawa, Takeshi, Yokoi, Takeshi, Nagai, Tomonori, Sato, Toyomi, Kamiura, Shoji, Fujishita, Akira, Loong, Wong Wai, and Chan, Karen

Subjects
OVARIAN tumors, CARBOPLATIN, INTRAVENOUS therapy, CONFIDENCE intervals, INTRAPERITONEAL injections, DISEASE incidence, RANDOMIZED controlled trials, TREATMENT effectiveness, DESCRIPTIVE statistics, STATISTICAL sampling, PACLITAXEL, PROGRESSION-free survival, DRUG side effects, OVERALL survival, PHARMACODYNAMICS
Abstract

Background: Intraperitoneal chemotherapy has been shown to be effective at reducing mortality for patients with advanced epithelial ovarian cancer but is not widely used in practice. Methods: We performed the Intraperitoneal Therapy for Ovarian Cancer with Carboplatin (iPocc) trial as an open-label, international, multi-institutional, randomized phase 2/3 clinical trial in women with newly diagnosed epithelial ovarian cancer who underwent laparotomy or laparoscopy. All patients received intravenous paclitaxel (80 mg/m² on days 1, 8, and 15 of a 21-day cycle). In addition, patients in the control group received intravenous carboplatin (dose-dense intravenous paclitaxel plus intravenous carboplatin [dd-TCiv]), whereas patients in the experimental group received dose-dense intravenous paclitaxel plus intraperitoneal carboplatin (dd-TCip). The primary end point was progression-free survival (PFS). Secondary end points included overall survival, tumor response, treatment completion rate, and incidence of adverse events (AEs). Results: Among 655 patients randomized to treatment, median (95% confidence interval [CI]) PFS was 20.7 (18.1 to 22.8) months for dd-TCiv (n=328) and 23.5 (20.5 to 26.9) months for dd-TCip (n=327; hazard ratio, 0.83; 95% CI, 0.69 to 0.99; P=0.04). The PFS benefit with dd-TCip was consistent in patients with different baseline characteristics, stage, size of residual tumor, age, and performance status. The treatment completion rates were 68.3 and 59.9% in the dd-TCiv and dd-TCip groups, respectively. The incidence of intraperitoneal catheter-related AEs in the dd-TCip group was 10.1%; there were no such AEs in the dd-TCiv group. Conclusions: In the first-line treatment of advanced epithelial ovarian cancer, intraperitoneal carboplatin resulted in a modest prolongation of PFS when given with dose-dense weekly paclitaxel regardless of residual tumor size, with no impact on noncatheter-related toxicities. (Funded by the Japan Agency for Medical Research and Development, and others; Japan Registry of Clinical Trials number, jRCTs031180141.) [ABSTRACT FROM AUTHOR]

Published
2023
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37. Saturday, July 13, 202410:30 AM - 11:30 AM GPP01 Presentation Time: 10:30 AM: A Phase 3 Study of Pembrolizumab (Pembro) + Chemoradiotherapy (CCRT) for High-Risk Locally Advanced Cervical Cancer (LACC)

Author

Romano, Kara D., Macchia, Gabriella, Christiaens, Melissa, Lalondrelle, Susan, Zhang, Xiang, De Melo, Andréia Cristina, Reginacova, Klaudia, Helpman, Limor, Ayhan, Ali, Zagouri, Flora, Woelber, Linn, Hellman, Kristina, Colombo, Nicoletta, Marin, Margarita Romeo, Berger, Regina, Fields, Emma, Lopez, Karla Alejandra, Castonguay, Vincent, Takehara, Kazuhiro, Chang, Ting-Chang, Yamada, Karin, Puglisi, Martina, Li, Kan, Cerrotta, Annamaria, and Lorusso, Domenica

Published
2024
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38. Poor Treatment Outcomes of Locally Advanced Cervical Adenocarcinoma of Human Papilloma Virus Independent Type, Represented by Gastric Type Adenocarcinoma: A Multi-Center Retrospective Study (Sankai Gynecology Study Group).

Author

Seki, Toshiyuki, Kojima, Atsumi, Okame, Shinichi, Yamaguchi, Satoshi, Okamoto, Aikou, Tokunaga, Hideki, Nishio, Shin, Takei, Yuji, Yokoyama, Yoshihito, Yoshida, Manabu, Teramoto, Norihiro, Mikami, Yoshiki, Shimada, Muneaki, Kigawa, Junzo, and Takehara, Kazuhiro

Subjects
ADENOCARCINOMA, PAPILLOMAVIRUSES, STOMACH tumors, TUMOR classification, TREATMENT effectiveness, DESCRIPTIVE statistics, CERVIX uteri tumors, PROGRESSION-free survival, OVERALL survival, EVALUATION
Abstract

Simple Summary: Cervical adenocarcinomas have been divided into human papilloma virus-associated (HPVa) and -independent (HPVi) tumors in the updated pathological classification issued by the World Health Organization in 2020. However, few studies have investigated the impact of this new classification on the treatment outcomes and prognosis of locally advanced cervical adenocarcinoma. We investigated the treatment outcomes of 103 and 48 patients with locally advanced (stages IB3–IIIC1) HPVa and HPVi cervical adenocarcinomas, respectively. Most patients underwent radical hysterectomy with or without adjuvant therapy for both tumor types. The overall survival time and survival to progression or death were significantly shorter in the HPVi group than in the HPVa group. In particular, patients with parametrial invasion had highly significant differences in survival. Only five patients with HPVi carcinomas received definitive radiotherapy, and all demonstrated a treatment response. HPVi tumors showed poor outcomes with the current treatment strategy. The revised World Health Organization classification of cervical cancer divides adenocarcinomas into human papillomavirus-associated (HPVa) and -independent (HPVi) types; the HPVi type is represented by the gastric type. The treatment outcomes of locally advanced adenocarcinoma (LaAC), based on this classification, are understudied. We investigated the outcomes of patients with HPVa and HPVi LaACs. Data for all consecutive patients with stage IB3 to IIIC1 adenocarcinoma who received treatment at 12 institutions throughout Japan between 2004 and 2009 were retrieved to analyze progression-free and overall survival. Central pathological review classified 103 and 48 patients as having HPVa and HPVi tumors, respectively. Usual- (84%) and gastric- (90%) type adenocarcinomas were the most frequent subtypes. Surgery was the primary treatment strategy for most patients. Progression-free and overall survival of patients with HPVi were worse than those of patients with HPVa (p = 0.009 and 0.032, respectively). Subgroup analysis by stage showed that progression-free survival was significantly different for stage IIB. The current surgical treatment strategy for LaACs is less effective for HPVi tumors than for HPVa tumors, especially those in stage IIB. [ABSTRACT FROM AUTHOR]

Published
2023
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39. Endometrial carcinosarcoma.

Author

Bogani, Giorgio, Ray-Coquard, Isabelle, Concin, Nicole, Yan Li Ngoi, Natalie, Morice, Philippe, Caruso, Giuseppe, Enomoto, Takayuki, Takehara, Kazuhiro, Denys, Hannelore, Lorusso, Domenica, Coleman, Robert, Vaughan, Michelle M., Masashi Takano, Provencher, Diane Michele, Sagae, Satoru, Wimberger, Pauline, Póka, Robert, Segev, Yakir, Se Ik Kim, and Jae-Weon Kim

Published
2023
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42. A Patient with Transverse Colon Cancer Complicated by Cowden Syndrome Administered FOLFOXIRI + Bevacizumab Therapy.

Author

Takehara, Kazuhiro, Ishizaki, Yoichi, Nagakari, Kunihiko, Ohuchi, Masakazu, Fukunaga, Masaki, and Sakamoto, Kazuhiro

Subjects
*COLON cancer, *HAMARTOMA, *BEVACIZUMAB, *TUMOR suppressor genes, *ADJUVANT chemotherapy, *PANITUMUMAB
Abstract

Cowden syndrome is characterized by several clinical features related to tumorous lesions primarily consisting of systemic hamartomas. The mutation of a tumor suppressor gene, the PTEN gene, is etiologically involved. As gastrointestinal lesions, polyps of all digestive tracts involving the esophagus to rectum develop. In patients with Cowden syndrome, the risk of colorectal cancer may increase. However, the characteristics of colorectal cancer in these patients remain to be clarified and sufficient findings regarding chemotherapy have not been obtained. A 39-year-old man was treated with a colonic stent for colitis obstructive due to circumferential transverse colon carcinoma. After decompression, elective extended laparoscopic right hemicolectomy was performed. Preoperative systemic detailed examination revealed characteristic dermal/mucosal findings, polyposis of the upper digestive tract, and a thyroid tumor. On PTEN gene sequencing, a mutation was detected at codon 130 of exon 5, leading to a diagnosis of Cowden syndrome. Postoperative adjuvant chemotherapy was performed for 6 months, but recurrent peritoneal dissemination was observed 1 month after its completion. FOLFOXIRI + bevacizumab therapy was started. Transiently, a partial response was achieved in peritoneally disseminated nodes according to the RECIST. There was no increase in the volume of cancerous ascites. However, an increase in the volume of ascites and local relapse were noted at the completion of the tenth course. The regimen was switched to FOLFIRI + panitumumab, but peritoneal dissemination exacerbated and the patient died 18 months after surgery. [ABSTRACT FROM AUTHOR]

Published
2023
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43. Clinical impact of systematic pelvic and para-aortic lymphadenectomy for pT1 and pT2 ovarian cancer: a retrospective survey by the Sankai Gynecology Study Group

Author

Oshita, Takafumi, Itamochi, Hiroaki, Nishimura, Ryuichiro, Numa, Fumitaka, Takehara, Kazuhiro, Hiura, Masamichi, Tanimoto, Hirotoshi, Noma, Jun, Hayase, Ryoji, Murakami, Akihiro, Fujimoto, Hideo, Kanamori, Yasunobu, Kitada, Fuminori, Shitsukawa, Keiji, Nagaji, Makoto, Minagawa, Yukihisa, Fujiwara, Michihisa, and Kigawa, Junzo

Published
2013
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44. Neoadjuvant Chemotherapy of Docetaxel and Carboplatin followed by Radical Hysterectomy could be Promising Treatment in Patients with Stage Ib2 to IIb usual-type Adenocarcinoma: Updated Result of an Advance Study of SGSG-005.: YGA O 04

Author

Kojima, Atsumi, Shimada, Muneaki, Nagao, Shoji, Takeshima, Nobuhiro, Shoji, Tadahiro, Sudo, Tamotsu, Hirata, Eiji, Takehara, Kazuhiro, Kanamori, Yasunobu, Hayase, Ryouji, Teramoto, Norihiro, Kiyokawa, Takako, Mikami, Yoshiki, Kigawa, Junzo, and Nishimura, Ryuichiro

Published
2015

46. Regional differences in human papillomavirus type 52 prevalence among Japanese women with cervical intraepithelial neoplasia†.

Author

Kukimoto, Iwao, Onuki, Mamiko, Yamamoto, Kasumi, Yahata, Hideaki, Aoki, Yoichi, Yokota, Harushige, Konnai, Katsuyuki, Nio, Ai, Takehara, Kazuhiro, Kamiura, Shoji, Tsuda, Naotake, Takei, Yuji, Shimada, Muneaki, Nakai, Hidekatsu, Yoshida, Hiroyuki, Motohara, Takeshi, Yamazaki, Hiroyuki, Nakamura, Keiichiro, Okunomiya, Asuka, and Tasaka, Nobutaka

Published
2022
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47. Lenvatinib plus pembrolizumab in Japanese patients with endometrial cancer: Results from Study 309/KEYNOTE‐775.

Author

Yonemori, Kan, Yunokawa, Mayu, Ushijima, Kimio, Sakata, Jun, Shikama, Ayumi, Minobe, Shinichiro, Usami, Tomoka, Enomoto, Takayuki, Takehara, Kazuhiro, Hasegawa, Kosei, Yamagami, Wataru, Yamamoto, Keiko, Han, Shirong, Dutta, Lea, Orlowski, Robert, Miura, Takuma, Makker, Vicky, and Fujiwara, Keiichi

Abstract

Study 309/KEYNOTE‐775 is a phase 3 open‐label, randomized trial of lenvatinib plus pembrolizumab versus treatment of physician's choice (TPC) in patients with advanced endometrial cancer with progression after platinum‐based therapy. Primary endpoints of superiority for lenvatinib plus pembrolizumab were met for progression‐free survival (PFS) and overall survival (OS) in all‐comers (ie, regardless of mismatch repair [MMR] status) and patients with MMR proficiency (pMMR). We present results for the Japanese subset. Patients were randomized to oral lenvatinib 20 mg/day plus intravenous pembrolizumab 200 mg every 3 weeks (Q3W; up to 35 cycles of pembrolizumab) or TPC (intravenous doxorubicin 60 mg/m2 Q3W or paclitaxel 80 mg/m2 QW [3 weeks on/1 week off]). Primary endpoints were PFS by blinded independent central review per RECIST version 1.1 and OS. One hundred four patients were randomized in Japan (data cutoff, October 26, 2020; median follow‐up, 11.8 [range, 1.1–26.9] months). Hazard ratios (HRs) for PFS with lenvatinib plus pembrolizumab versus TPC were 1.04 (95% CI, 0.63–1.73) in patients with pMMR and 0.81 (0.50–1.31) in all‐comers. Hazard ratios for OS were 0.74 (0.41–1.34) with pMMR and 0.59 (0.33–1.04) for all‐comers. Adverse events were manageable and led to discontinuation of one/both study drugs in 36.5% of patients in the lenvatinib plus pembrolizumab group versus 7.8% in the TPC group. Similar to the global Study 309/KEYNOTE‐775 results, this analysis suggested favorable efficacy and manageable safety with lenvatinib plus pembrolizumab after platinum‐based chemotherapy in Japanese patients with advanced endometrial cancer and supports this combination as a new standard of care in this population. [ABSTRACT FROM AUTHOR]

Published
2022
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48. Tisotumab vedotin in Japanese patients with recurrent/metastatic cervical cancer: Results from the innovaTV 206 study.

Author

Yonemori, Kan, Kuboki, Yasutoshi, Hasegawa, Kosei, Iwata, Takashi, Kato, Hidenori, Takehara, Kazuhiro, Hirashima, Yasuyuki, Kato, Hisamori, Passey, Chaitali, Buchbjerg, Jeppe Klint, Harris, Jeffrey R., Andreassen, Camilla Mondrup, Nicacio, Leonardo, Soumaoro, Ibrahima, and Fujiwara, Keiichi

Abstract

New treatments, particularly second‐line options, are needed to improve outcomes for patients with recurrent/metastatic cervical cancer (r/mCC). Tisotumab vedotin (TV) is an antibody–drug conjugate directed to tissue factor, a transmembrane protein commonly expressed in cancer cells, to deliver cytotoxic monomethyl auristatin E. This single‐arm, open‐label phase 1/2 trial evaluated the consistency of safety and efficacy outcomes of TV in Japanese patients with r/mCC to bridge the current findings with those reported in previous trials in non‐Japanese patients in the United States and Europe. In part 1 (dose escalation; N = 6), patients with advanced solid tumors received TV 1.5 or 2.0 mg/kg once every 3 weeks to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Part 2 (dose expansion; N = 17) evaluated the RP2D in r/mCC patients with 1–2 prior lines of therapy. In part 1, no dose‐limiting toxicities were observed, the MTD was not reached, and TV 2.0 mg/kg was established as the RP2D. In part 2, the most common treatment‐emergent adverse events were anemia (58.8%), nausea (58.8%), alopecia (47.1%), epistaxis (47.1%), and diarrhea (35.3%); adverse events of special interest were bleeding (76.5%), ocular events (35.3%), and peripheral neuropathy (17.6%), and were mostly grade 1/2. In part 2, confirmed objective response rate was 29.4%, median duration of response was 7.1 months, and median time to response was 1.2 months. In Japanese patients with r/mCC, TV demonstrated a manageable and tolerable safety, pharmacokinetics, and efficacy profile consistent with that observed in non‐Japanese patients. [ABSTRACT FROM AUTHOR]

Published
2022
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