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2. Secondary azoospermia after sleeve gastrectomy: a case report

Author

Gricelda Gomez, M.D., M.P.H., Alexandra Berger, M.D., and Martin Kathrins, M.D.

Subjects
Azoospermia, bariatric surgery, sleeve gastrectomy, testosterone deficiency, Diseases of the genitourinary system. Urology, RC870-923, Gynecology and obstetrics, RG1-991
Abstract

Objective: To report the first case of secondary azoospermia after sleeve gastrectomy. Design: Case report. Setting: Academic male infertility clinic. Patient(s): A 33-year-old man with secondary azoospermia and primary testicular failure with testosterone deficiency after laparoscopic sleeve gastrectomy. Intervention(s): Hormonal therapy with anastrozole for 10 months and diagnostic testicular biopsy. Main Outcome Measure(s): Semen analyses and testicular histopathology. Result(s): Non-obstructive azoospermia persisted at 20 months after surgery despite hormonal therapy with anastrozole. Testicular histopathology revealed the presence of Sertoli cells only. Conclusion(s): Although further research is need to determine the relationship between sleeve gastrectomy and secondary infertility, men should be informed of the potentially deleterious effects of this surgery on semen parameters.

Published
2021
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5. Calvarial aneurysmal bone cyst associated with fibrous dysplasia: Case report and literature review

Author

Harjus Birk, B.S., Ethan A. Winkler, M.D. Ph.D., Phillip A. Bonney, B.S., Mitchel S. Berger, M.D., and Michael W. McDermott, M.D.

Subjects
Bone cyst, Calvarium, McCune-Albright syndrome, In situ cranioplasty, Cosmesis, Surgery, RD1-811, Neurology. Diseases of the nervous system, RC346-429
Abstract

Aneurysmal bone cysts are benign, expansile bone lesions primary or secondary to other pathology. The majority are seen in long bones and the spine, rarely occurring within the cranial vault. Here we describe the case of a 17-year-old gentleman with McCune-Albright syndrome who developed a right parietal aneurysmal bone cyst in the setting of fibrous dysplasia. The patient was treated with lesion excision and in situ cranioplasty using methyl methacrylate and molded titanium mesh, ultimately rendering excellent cosmetic outcome. Our case report highlights the efficacy of in situ titanium cranioplasties in contouring to the native skull and enabling optimization of cosmesis, specifically through the use of titanium mesh plates with the bone flap as a template.

Published
2017
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6. 431P Neoadjuvant treatment with regorafenib and capecitabine combined with radiotherapy in locally advanced rectal cancer: A multicenter phase Ib trial (RECAP) SAKK 41/16

Author

Bastian, S., primary, Joerger, M., additional, Baertschi, D., additional, Holer, L., additional, Guckenberger, M., additional, Jochum, W., additional, Koeberle, D., additional, Siebenhüner, A.R., additional, Berger, M.D., additional, Winterhalder, R.C., additional, Largiadèr, C.R., additional, Löffler-Baumann, M., additional, Mosna- Firlejczyk, K., additional, Wicki, A., additional, Fischer Maranta, A., additional, and von Moos, R.A.F., additional

Published
2022
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7. Clinical Performance of the Consensus Immunoscore in Colon Cancer in the Asian Population from the Multicenter International SITC Study

Author

Mlecnik, B., Torigoe, T., Bindea, G., Popivanova, B., Xu, M., Fujita, T., Hazama, S., Suzuki, N., Nagano, H., Okuno, K., Hirohashi, Y., Furuhata, T., Takemasa, I., Patel, P., Vora, H., Shah, B., Patel, J.B., Rajvik, K.N., Pandya, S.J., Shukla, S.N., Wang, Yili, Zhang, G., Yoshino, T., Taniguchi, H., Bifulco, C., Lugli, A., Lee, J.J., Zlobec, I., Rau, T.T., Berger, M.D., Nagtegaal, I.D., Vink-Borger, Elisa, Hartmann, A., Geppert, C.I., Kolwelter, J., Merkel, S., Grützmann, R., Eynde, M. Van den, Jouret-Mourin, A., Kartheuser, A., Léonard, D., Remue, C., Wang, J., Bavi, P., Roehrl, M.H.A., Ohashi, P.S., Nguyen, L.T., Han, S., MacGregor, H.L., Hafezi-Bakhtiari, S., Wouters, B.G., Masucci, G.V., Andersson, E., Zavadova, E., Vocka, M., Spacek, J., Petruzelka, L., Konopasek, B., Dundr, P., Skalova, H., Nemejcova, K., Botti, G., Tatangelo, F., Delrio, P., Ciliberto, G., Maio, M, Laghi, L., Grizzi, F., Marliot, F., Fredriksen, T., Buttard, B., Lafontaine, L., Maby, P., Majdi, A., Hijazi, A., Sissy, C. El, Kirilovsky, A., Berger, A., Lagorce, C., Paustian, C., Ballesteros-Merino, C., Dijkstra, J.R., Water, C. van de, Lent-van Vliet, S. van, Knijn, N., Mușină, A.M., Scripcariu, D.V., Marincola, F.M., Ascierto, P.A., Fox, B.A., Pagès, F., Kawakami, Y., Galon, J., Mlecnik, B., Torigoe, T., Bindea, G., Popivanova, B., Xu, M., Fujita, T., Hazama, S., Suzuki, N., Nagano, H., Okuno, K., Hirohashi, Y., Furuhata, T., Takemasa, I., Patel, P., Vora, H., Shah, B., Patel, J.B., Rajvik, K.N., Pandya, S.J., Shukla, S.N., Wang, Yili, Zhang, G., Yoshino, T., Taniguchi, H., Bifulco, C., Lugli, A., Lee, J.J., Zlobec, I., Rau, T.T., Berger, M.D., Nagtegaal, I.D., Vink-Borger, Elisa, Hartmann, A., Geppert, C.I., Kolwelter, J., Merkel, S., Grützmann, R., Eynde, M. Van den, Jouret-Mourin, A., Kartheuser, A., Léonard, D., Remue, C., Wang, J., Bavi, P., Roehrl, M.H.A., Ohashi, P.S., Nguyen, L.T., Han, S., MacGregor, H.L., Hafezi-Bakhtiari, S., Wouters, B.G., Masucci, G.V., Andersson, E., Zavadova, E., Vocka, M., Spacek, J., Petruzelka, L., Konopasek, B., Dundr, P., Skalova, H., Nemejcova, K., Botti, G., Tatangelo, F., Delrio, P., Ciliberto, G., Maio, M, Laghi, L., Grizzi, F., Marliot, F., Fredriksen, T., Buttard, B., Lafontaine, L., Maby, P., Majdi, A., Hijazi, A., Sissy, C. El, Kirilovsky, A., Berger, A., Lagorce, C., Paustian, C., Ballesteros-Merino, C., Dijkstra, J.R., Water, C. van de, Lent-van Vliet, S. van, Knijn, N., Mușină, A.M., Scripcariu, D.V., Marincola, F.M., Ascierto, P.A., Fox, B.A., Pagès, F., Kawakami, Y., and Galon, J.

Abstract

Contains fulltext : 283495.pdf (Publisher’s version ) (Open Access), BACKGROUND: In this study, we evaluated the prognostic value of Immunoscore in patients with stage I-III colon cancer (CC) in the Asian population. These patients were originally included in an international study led by the Society for Immunotherapy of Cancer (SITC) on 2681 patients with AJCC/UICC-TNM stages I-III CC. METHODS: CD3+ and cytotoxic CD8+ T-lymphocyte densities were quantified in the tumor and invasive margin by digital pathology. The association of Immunoscore with prognosis was evaluated for time to recurrence (TTR), disease-free survival (DFS), and overall survival (OS). RESULTS: Immunoscore stratified Asian patients (n = 423) into different risk categories and was not impacted by age. Recurrence-free rates at 3 years were 78.5%, 85.2%, and 98.3% for a Low, Intermediate, and High Immunoscore, respectively (HR[Low-vs-High] = 7.26 (95% CI 1.75-30.19); p = 0.0064). A High Immunoscore showed a significant association with prolonged TTR, OS, and DFS (p < 0.05). In Cox multivariable analysis stratified by center, Immunoscore association with TTR was independent (HR[Low-vs-Int+High] = 2.22 (95% CI 1.10-4.55) p = 0.0269) of the patient's gender, T-stage, N-stage, sidedness, and MSI status. A significant association of a High Immunoscore with prolonged TTR was also found among MSS (HR[Low-vs-Int+High] = 4.58 (95% CI 2.27-9.23); p ≤ 0.0001), stage II (HR[Low-vs-Int+High] = 2.72 (95% CI 1.35-5.51); p = 0.0052), low-risk stage-II (HR[Low-vs-Int+High] = 2.62 (95% CI 1.21-5.68); p = 0.0146), and high-risk stage II patients (HR[Low-vs-Int+High] = 3.11 (95% CI 1.39-6.91); p = 0.0055). CONCLUSION: A High Immunoscore is significantly associated with the prolonged survival of CC patients within the Asian population.

Published
2022

9. Tumour budding in solid cancers

Author

Lugli, A., Zlobec, I., Berger, M.D., Kirsch, R., Nagtegaal, I.D., Lugli, A., Zlobec, I., Berger, M.D., Kirsch, R., and Nagtegaal, I.D.

Abstract

Item does not contain fulltext, Tumour budding is an emerging prognostic biomarker in colorectal cancer (CRC) and other solid cancers. Tumour buds are usually defined as isolated single cancer cells or clusters of up to four cancer cells located at the invasive tumour front. The prognostic value of tumour budding is now supported by a large body of evidence, whereas the utility of this phenotype as a predictive biomarker remains under investigation. The application of tumour budding indices in clinical practice requires a standardized scoring system that can be tailored to specific tumour types and clinical scenarios. In the context of CRC, tumour budding can be assessed according to the method agreed at the International Tumour Budding Consensus Conference (ITBCC) in 2016. Using the ITBCC scoring system, tumour budding is an independent predictor of lymph node metastasis in patients with pT1 CRC and of unfavourable survival in patients with stage II colon cancer. Regardless of the clinical scenario or tumour type, the assertion that 'the more tumour buds, the worse the clinical outcome' applies. In this Review, we provide an overview of tumour budding in solid cancers, highlighting the molecular and biological aspects of this phenomenon, including its associations with epithelial-mesenchymal transition and features of the tumour microenvironment. We also describe the available evidence demonstrating the value of tumour budding as a biomarker across various solid cancers.

Published
2021

11. Efficacy and Safety of Azelastine 0.15% Nasal Spray and Azelastine 0.10% Nasal Spray in Patients with Seasonal Allergic Rhinitis

Author

Shailen Shah M.D., William Berger M.D., William Lumry M.D., Craig La Force M.D., William Wheeler Ph.D., and Harry Sacks M.D.

Subjects
Otorhinolaryngology, RF1-547, Immunologic diseases. Allergy, RC581-607
Abstract

Azelastine is a second-generation antihistamine approved for treatment of allergic rhinitis. This randomized, double-blind, placebo- and active-controlled, parallel-group clinical trial evaluated the efficacy and safety of azelastine 0.15% and azelastine 0.10% nasal spray at a dosage of 2 sprays/nostril twice daily in patients with moderate-to-severe seasonal allergic rhinitis (SAR). In total, 526 patients were randomized 1:1:1 to treatment with 2 sprays/nostril twice daily of azelastine 0.15%, azelastine 0.10%, or placebo. The primary efficacy variable was change from baseline in 12-hour reflective Total Nasal Symptom Score (TNSS; A.M. and P.M. combined), consisting of nasal congestion, rhinorrhea, itchy nose, and sneezing. After 2 weeks, the mean improvement and percentage improvement in the 12-hour reflective TNSS were significant (p < 0.001) with azelastine 0.15% and azelastine 0.10% compared with placebo. In a retrospective analysis, there was a statistical difference (p = 0.047) in the mean improvement versus placebo in the 12-hour reflective TNSS with azelastine 0.15% compared with azelastine 0.10%. Onset of action with azelastine 0.15% was within 30 minutes. Bitter taste was the most common adverse event with both azelastine 0.15% and azelastine 0.10% (8.4% and 9.4% of patients, respectively). Somnolence was reported by 1.7% of patients treated with azelastine 0.15%, 0.6% of patients treated with azelastine 0.10%, and 0.6% of patients treated with placebo. Azelastine 0.15% nasal spray at 2 sprays/nostril twice daily significantly improved the nasal symptoms associated with SAR with an onset of action within 30 minutes and was well tolerated.

Published
2010
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12. Genetic variants in the one-carbon metabolism pathway to predict outcome in patients with metastatic colorectal cancer (mCRC): Data from TRIBE and FIRE-3 phase III trials

Author

Puccini, A., primary, Loupakis, F., additional, Stintzing, S., additional, Cao, S., additional, Millstein, J., additional, Battaglin, F., additional, Berger, M.D., additional, Togunaka, R., additional, Naseem, M., additional, Zhang, W., additional, Cremolini, C., additional, Falcone, A., additional, Heinemann, V., additional, and Lenz, H.J., additional

Published
2019
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13. Comprehensive molecular characterization of brain metastases (BM) from colorectal cancer (CRC)

Author

Battaglin, F., primary, Xiu, J., additional, Baca, Y., additional, Goldberg, R.M., additional, Grothey, A., additional, Shields, A.F., additional, Seeber, A., additional, Salem, M.E., additional, Puccini, A., additional, Tokunaga, R., additional, Naseem, M., additional, Arai, H., additional, Wang, J., additional, Berger, M.D., additional, Zhang, W., additional, Philip, P.A., additional, Marshall, J.L., additional, Korn, W.M., additional, and Lenz, H.J., additional

Published
2019
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14. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study

Author

Pages, F., Mlecnik, B., Marliot, F., Bindea, G., Ou, F.S., Bifulco, C., Lugli, A., Zlobec, I., Rau, T.T., Berger, M.D., Nagtegaal, I.D., Vink-Borger, E., Hartmann, A., Geppert, C., Kolwelter, J., Merkel, S., Grutzmann, R., Eynde, M. Van den, Jouret-Mourin, A., Kartheuser, A., Leonard, D., Remue, C., Wang, J.Y., Bavi, P., Roehrl, M.H.A., Ohashi, P.S., Nguyen, L.T., Han, S., MacGregor, H.L., Hafezi-Bakhtiari, S., Wouters, B.G., Masucci, G.V., Andersson, E.K., Zavadova, E., Vocka, M., Spacek, J., Petruzelka, L., Konopasek, B., Dundr, P., Skalova, H., Nemejcova, K., Botti, G., Tatangelo, F., Delrio, P., Ciliberto, G., Maio, M, Laghi, L., Grizzi, F., Fredriksen, T., Buttard, B., Angelova, M., Vasaturo, A., Maby, P., Church, S.E., Angell, H.K., Lafontaine, L., Bruni, D., Sissy, C. El, Haicheur, N., Kirilovsky, A., Berger, A., Lagorce, C., Meyers, J.P., Paustian, C., Feng, Z., Ballesteros-Merino, C., Dijkstra, J., Water, C. van de, Vliet, S. van, Knijn, N., Musina, A.M., Scripcariu, D.V., Popivanova, B., Xu, M., Fujita, T., Hazama, S., Suzuki, N., Nagano, H., Okuno, K., Torigoe, T., Sato, N., Furuhata, T., Takemasa, I., Itoh, K., Patel, P.S., Vora, H.H., Shah, B., Patel, J.B., Rajvik, K.N., Pandya, S.J., Shukla, S.N., Wang, Y., Zhang, G., Kawakami, Y., Marincola, F.M., Ascierto, P.A., Sargent, D.J., Fox, B.A., Galon, J., Pages, F., Mlecnik, B., Marliot, F., Bindea, G., Ou, F.S., Bifulco, C., Lugli, A., Zlobec, I., Rau, T.T., Berger, M.D., Nagtegaal, I.D., Vink-Borger, E., Hartmann, A., Geppert, C., Kolwelter, J., Merkel, S., Grutzmann, R., Eynde, M. Van den, Jouret-Mourin, A., Kartheuser, A., Leonard, D., Remue, C., Wang, J.Y., Bavi, P., Roehrl, M.H.A., Ohashi, P.S., Nguyen, L.T., Han, S., MacGregor, H.L., Hafezi-Bakhtiari, S., Wouters, B.G., Masucci, G.V., Andersson, E.K., Zavadova, E., Vocka, M., Spacek, J., Petruzelka, L., Konopasek, B., Dundr, P., Skalova, H., Nemejcova, K., Botti, G., Tatangelo, F., Delrio, P., Ciliberto, G., Maio, M, Laghi, L., Grizzi, F., Fredriksen, T., Buttard, B., Angelova, M., Vasaturo, A., Maby, P., Church, S.E., Angell, H.K., Lafontaine, L., Bruni, D., Sissy, C. El, Haicheur, N., Kirilovsky, A., Berger, A., Lagorce, C., Meyers, J.P., Paustian, C., Feng, Z., Ballesteros-Merino, C., Dijkstra, J., Water, C. van de, Vliet, S. van, Knijn, N., Musina, A.M., Scripcariu, D.V., Popivanova, B., Xu, M., Fujita, T., Hazama, S., Suzuki, N., Nagano, H., Okuno, K., Torigoe, T., Sato, N., Furuhata, T., Takemasa, I., Itoh, K., Patel, P.S., Vora, H.H., Shah, B., Patel, J.B., Rajvik, K.N., Pandya, S.J., Shukla, S.N., Wang, Y., Zhang, G., Kawakami, Y., Marincola, F.M., Ascierto, P.A., Sargent, D.J., Fox, B.A., and Galon, J.

Abstract

Contains fulltext : 193579.pdf (publisher's version ) (Closed access), BACKGROUND: The estimation of risk of recurrence for patients with colon carcinoma must be improved. A robust immune score quantification is needed to introduce immune parameters into cancer classification. The aim of the study was to assess the prognostic value of total tumour-infiltrating T-cell counts and cytotoxic tumour-infiltrating T-cells counts with the consensus Immunoscore assay in patients with stage I-III colon cancer. METHODS: An international consortium of 14 centres in 13 countries, led by the Society for Immunotherapy of Cancer, assessed the Immunoscore assay in patients with TNM stage I-III colon cancer. Patients were randomly assigned to a training set, an internal validation set, or an external validation set. Paraffin sections of the colon tumour and invasive margin from each patient were processed by immunohistochemistry, and the densities of CD3+ and cytotoxic CD8+ T cells in the tumour and in the invasive margin were quantified by digital pathology. An Immunoscore for each patient was derived from the mean of four density percentiles. The primary endpoint was to evaluate the prognostic value of the Immunoscore for time to recurrence, defined as time from surgery to disease recurrence. Stratified multivariable Cox models were used to assess the associations between Immunoscore and outcomes, adjusting for potential confounders. Harrell's C-statistics was used to assess model performance. FINDINGS: Tissue samples from 3539 patients were processed, and samples from 2681 patients were included in the analyses after quality controls (700 patients in the training set, 636 patients in the internal validation set, and 1345 patients in the external validation set). The Immunoscore assay showed a high level of reproducibility between observers and centres (r=0.97 for colon tumour; r=0.97 for invasive margin; p<0.0001). In the training set, patients with a high Immunoscore had the lowest risk of recurrence at 5 years (14 [8%] patients with a high Immunosc

Published
2018

15. Molecular differences between colorectal cancers with mutations in histone modifiers genes vs wild-type (WT) tumors

Author

Puccini, A., primary, Poorman, K., additional, Goldberg, R., additional, Shields, A.F., additional, Winerip, M., additional, Korn, W.M., additional, Berger, M.D., additional, Tokunaga, R., additional, Naseem, M., additional, Battaglin, F., additional, Zhang, W., additional, Soni, S., additional, Hwang, J.J., additional, Philip, P., additional, Marshall, J.L., additional, and Lenz, H.-J., additional

Published
2018
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16. Genetic variations within the HER3 gene predict outcome for mCRC patients treated with first-line FOLFIRI/bevacizumab or FOLFIRI/cetuximab: Data from FIRE-3

Author

Berger, M.D., primary, Stintzing, S., additional, Heinemann, V., additional, Cao, S., additional, Yang, D., additional, Miyamoto, Y., additional, Suenaga, M., additional, Hanna, D.L., additional, Soni, S., additional, Puccini, A., additional, Tokunaga, R., additional, Naseem, M., additional, Battaglin, F., additional, McSkane, M., additional, Zhang, W., additional, and Lenz, H.-J., additional

Published
2018
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19. Tandem repeat variation in HIC1 gene predicts outcome for oxaliplatin-based chemotherapy in patients with metastatic colorectal cancer

Author

Okazaki, S., primary, Loupakis, F., additional, Schirripa, M., additional, Cao, S., additional, Zhang, W., additional, Yang, D., additional, Ning, Y., additional, Berger, M.D., additional, Miyamoto, Y., additional, Suenaga, M., additional, Gopez, R., additional, Borelli, B.B., additional, Cremolini, C., additional, Falcone, A., additional, Lonardi, S., additional, Salvatore, L., additional, Uetake, H., additional, Kawano, T., additional, Helentjaris, T., additional, and Lenz, H.-J., additional

Published
2016
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20. Variations in genes regulating tumor-associated macrophages (TAMs) to predict outcomes of bevacizumab-based treatment in patients with metastatic colorectal cancer: results from TRIBE and FIRE3 trials

Author

Sunakawa, Y., primary, Stintzing, S., additional, Cao, S., additional, Heinemann, V., additional, Cremolini, C., additional, Falcone, A., additional, Yang, D., additional, Zhang, W., additional, Ning, Y., additional, Stremitzer, S., additional, Matsusaka, S., additional, Yamauchi, S., additional, Parekh, A., additional, Okazaki, S., additional, Berger, M.D., additional, Graver, S., additional, Mendez, A., additional, Scherer, S.J., additional, Loupakis, F., additional, and Lenz, H.-J., additional

Published
2015
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23. Abciximab and Heparin versus Bivalirudin for Non\u2013ST-Elevation Myocardial Infarction

Author

Adnan Kastrati, M.D, Franz-Josef Neumann, M.D, Stefanie Schulz, M.D, Steffen Massberg, M.D, Robert A. Byrne, M.B, B.Ch, Ph.D, Miroslaw Ferenc, M.D, Karl-Ludwig Laugwitz, M.D, Jxfcrgen Pache, M.D, Ilka Ott, M.D, Jxf6rg Hausleiter, M.D, Melchior Seyfarth, M.D, Michael Gick, M.D, David Antoniucci, M.D, Albert Schxf6mig M.D, Peter B. Berger, M.D, Julinda Mehilli, M.D, and for the ISAR-REACT 4 Trial Investigators

Published
2011

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