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6. Chemoradiotherapy plus induction or consolidation chemotherapy as total neoadjuvant therapy for locally advanced rectal cancer: Pooled analysis of the CAO/ARO/AIO-12 and the OPRA randomized phase 2 trials

Author

Fokas, Emmanouil, Williams, Hannah, Diefenhardt, Markus, Lin, Sabrina, Qin, Li-Xuan, Piso, Pompiliu, Dapper, Hendrik, Germer, Christoph-Thomas, Grützmann, Robert, Tim Friede, J., Joshua Smith, J., Saltz, Leonard B., Wu, Abraham J., Weiser, Martin R., Omer, Dana, Ghadimi, Michael, Hofheinz, Ralf-Dieter, Garcia-Aguilar, Julio, and Rödel, Claus

Published
2024
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7. Rectal Cancer

Author

Fokas, Emmanouil, Gani, Cihan, Valentini, Vincenzo, Rödel, Claus, Gambacorta, Maria Antonietta, Grosu, Anca-Ligia, editor, Nieder, Carsten, editor, and Nicolay, Nils Henrik, editor

Published
2023
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8. The value of subcutaneous xenografts for individualised radiotherapy in HNSCC: Robust gene signature correlates with radiotherapy outcome in patients and xenografts

Author

Linge, Annett, Patil, Shivaprasad, Grosser, Marianne, Lohaus, Fabian, Gurtner, Kristin, Kemper, Max, Gudziol, Volker, Haim, Dominik, Nowak, Alexander, Tinhofer, Inge, Zips, Daniel, Guberina, Maja, Stuschke, Martin, Balermpas, Panagiotis, Rödel, Claus, Schäfer, Henning, Grosu, Anca-Ligia, Abdollahi, Amir, Debus, Jürgen, Ganswindt, Ute, Belka, Claus, Pigorsch, Steffi, Combs, Stephanie E., Boeke, Simon, Gani, Cihan, Jöhrens, Korinna, Baretton, Gustavo B., Löck, Steffen, Baumann, Michael, and Krause, Mechthild

Published
2024
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11. Prevalence and implications of significance testing for baseline covariate imbalance in randomised cancer clinical trials: The Table 1 Fallacy

Author

Sherry, Alexander D., Msaouel, Pavlos, McCaw, Zachary R., Abi Jaoude, Joseph, Hsu, Eric J., Kouzy, Ramez, Patel, Roshal, Yang, Yumeng, Lin, Timothy A., Taniguchi, Cullen M., Rödel, Claus, Fokas, Emmanouil, Tang, Chad, Fuller, Clifton David, Minsky, Bruce, Meirson, Tomer, Sun, Ryan, and Ludmir, Ethan B.

Published
2023
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14. Clinical outcome after total neoadjuvant treatment (CAO/ARO/AIO-12) versus intensified neoadjuvant and adjuvant treatment (CAO/ARO/AIO-04) a comparison between two multicenter randomized phase II/III trials

Author

Diefenhardt, Markus, Fleischmann, Maximillian, Martin, Daniel, Hofheinz, Ralf-Dieter, Piso, Pompiliu, Germer, Christoph-Thomas, Hambsch, Peter, Grützmann, Robert, Kirste, Simon, Schlenska-Lange, Anke, Ghadimi, Michael, Rödel, Claus, and Fokas, Emmanouil

Published
2023
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18. Long‐Term Experience of Chemoradiotherapy Combined with Deep Regional Hyperthermia for Organ Preservation in High‐Risk Bladder Cancer (Ta, Tis, T1, T2)

Author

Merten, Ricarda, Ott, Oliver, Haderlein, Marlen, Bertz, Simone, Hartmann, Arndt, Wullich, Bernd, Keck, Bastian, Kühn, Reinhard, Rödel, Claus Michael, Weiss, Christian, Gall, Christine, Uter, Wolfgang, and Fietkau, Rainer

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Cancer, Urologic Diseases, Clinical Research, Clinical Trials and Supportive Activities, 6.4 Surgery, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Chemoradiotherapy, Combined Modality Therapy, Female, Humans, Hyperthermia, Induced, Male, Middle Aged, Neoplasm Staging, Organ Preservation, Randomized Controlled Trials as Topic, Retrospective Studies, Urinary Bladder Neoplasms, Bladder cancer, Bladder preservation, Hyperthermia, Radiotherapy, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundThe aim of this study was to evaluate the efficacy and safety of chemoradiotherapy (RCT) combined with regional deep hyperthermia (RHT) of high-risk bladder cancer after transurethral resection of bladder tumor (TUR-BT).Materials and methodsBetween 1982 and 2016, 369 patients with pTa, pTis, pT1, and pT2 cN0-1 cM0 bladder cancer were treated with a multimodal treatment after TUR-BT. All patients received radiotherapy (RT) of the bladder and regional lymph nodes. RCT was administered to 215 patients, RCT + RHT was administered to 79 patients, and RT was used in 75 patients. Treatment response was evaluated 4-6 weeks after treatment with TUR-BT.ResultsComplete response (CR) overall was 83% (290/351), and in treatment groups was RT 68% (45/66), RCT 86% (178/208), and RCT + RHT 87% (67/77). CR was significantly improved by concurrent RCT compared with RT (odds ratio [OR], 2.32; 95% confidence interval [CI], 1.05-5.12; p = .037), less influenced by hyperthermia (OR, 2.56; 95% CI, 0.88-8.00; p = .092). Overall survival (OS) after RCT was superior to RT (hazard ratio [HR], 0.7; 95% CI, 0.50-0.99; p = .045). Five-year OS from unadjusted Kaplan-Meier estimates was RCT 64% versus RT 45%. Additional RHT increased 5-year OS to 87% (HR, 0.32; 95% CI, 0.18-0.58; p = .0001). RCT + RHT compared with RCT showed a significantly better bladder-preservation rate (HR, 0.13; 95% CI, 0.03-0.56; p = .006). Median follow-up was 71 months. The median number of RHT sessions was five.ConclusionThe multimodal treatment consisted of a maximal TUR-BT followed by RT; concomitant platinum-based chemotherapy combined with RHT in patients with high-grade bladder cancer improves local control, bladder-preservation rate, and OS. It offers a promising alternative to surgical therapies like radical cystectomy.Implications for practiceRadical cystectomy with appropriate lymph node dissection has long represented the standard of care for muscle-invasive bladder cancer in medically fit patients, despite many centers reporting excellent long-term results for bladder preserving strategies. This retrospective analysis compares different therapeutic modalities in bladder-preservation therapy. The results of this study show that multimodal treatment consisting of maximal transurethral resection of bladder tumor followed by radiotherapy, concomitant platinum-based chemotherapy combined with regional deep hyperthermia in patients with Ta, Tis, T1-2 bladder carcinomas improves local control, bladder-preservation rate, and survival. More importantly, these findings offer a promising alternative to surgical therapies like radical cystectomy. The authors hope that, in the future, closer collaboration between urologists and radiotherapists will further improve treatments and therapies for the benefit of patients.

Published
2019

22. Development and validation of a 6-gene signature for the prognosis of loco-regional control in patients with HPV-negative locally advanced HNSCC treated by postoperative radio(chemo)therapy

Author

Patil, Shivaprasad, Linge, Annett, Grosser, Marianne, Lohaus, Fabian, Gudziol, Volker, Kemper, Max, Nowak, Alexander, Haim, Dominik, Tinhofer, Inge, Budach, Volker, Guberina, Maja, Stuschke, Martin, Balermpas, Panagiotis, Rödel, Claus, Schäfer, Henning, Grosu, Anca-Ligia, Abdollahi, Amir, Debus, Jürgen, Ganswindt, Ute, Belka, Claus, Pigorsch, Steffi, Combs, Stephanie E., Boeke, Simon, Zips, Daniel, Baretton, Gustavo B., Baumann, Michael, Krause, Mechthild, and Löck, Steffen

Published
2022
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24. Bayesian network structure for predicting local tumor recurrence in rectal cancer patients treated with neoadjuvant chemoradiation followed by surgery

Author

Osong, Biche, Masciocchi, Carlotta, Damiani, Andrea, Bermejo, Inigo, Meldolesi, Elisa, Chiloiro, Giuditta, Berbee, Maaike, Lee, Seok Ho, Dekker, Andre, Valentini, Vincenzo, Gerard, Jean-Pierre, Rödel, Claus, Bujko, Krzysztof, van de Velde, Cornelis, Folkesson, Joakim, Sainato, Aldo, Glynne-Jones, Robert, Ngan, Samuel, Brændengen, Morten, Sebag-Montefiore, David, and van Soest, Johan

Published
2022
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25. Tumor Response and Its Impact on Treatment Failure in Rectal Cancer: Does Intensity of Neoadjuvant Treatment Matter?

Author

Diefenhardt, Markus, Martin, Daniel, Fleischmann, Maximilian, Hofheinz, Ralf-Dieter, Ghadimi, Michael, Rödel, Claus, and Fokas, Emmanouil

Subjects
DATA analysis, RESEARCH funding, TREATMENT effectiveness, CANCER patients, DESCRIPTIVE statistics, RECTUM tumors, LONGITUDINAL method, ADJUVANT chemotherapy, COMBINED modality therapy, STATISTICS, TREATMENT failure, COMPARATIVE studies, TUMOR classification, DISEASE incidence
Abstract

Simple Summary: The response to neoadjuvant treatment in rectal cancer varies among patients, while the evidence of benefit from additional adjuvant chemotherapy, especially in patients with persistent tumor and/or lymph node metastases, is unclear. In our cohort study of 1778 patients, we showed that persistent tumor and/or lymph node metastasis after intensified neoadjuvant treatment, e.g., total neoadjuvant treatment (TNT), was not more strongly associated with an extensive risk of treatment failure (TF, local recurrence and/or distant metastasis) than after less intensive neoadjuvant treatment, e.g., 5-flurouracil-based chemoradiotherapy (5-FU CRT). These results may help clinicians to individualize their surveillance strategies, but do not provide an argument for adding additional chemotherapy in non-responders after TNT. Objectives: Additional adjuvant treatment in patients with rectal cancer with limited response to neoadjuvant treatment to mitigate their higher risk of treatment failure remains controversial. Methods: This is a post hoc analysis of a cohort study of 3 randomized phase 2 or 3 trials (CAO/ARO/AIO-94, -04, and -12 trial) that included 1948 patients with locally advanced rectal adenocarcinoma. After excluding patients with missing information, 1788 patients (1254 men and 524 women; median age: 62.6 years, age range: 19–84 years) were eligible. We analyzed the extent of tumor response and its association with the incidence of treatment failure after different neoadjuvant treatment approaches. Results: Tumor response was significantly enhanced with more intensive neoadjuvant treatment. After a median follow-up of 55 months for the entire cohort (IQR: 37 months–62 months), the incidence of treatment failure (TF) stratified by tumor response or post-neoadjuvant pathological outcome was not significantly affected by the intensity of neoadjuvant treatment, whereas the ypTNM stage was significantly associated with the risk of treatment failure. Conclusions: In this cohort study, we provide evidence that limited or no response to intensified neoadjuvant treatment protocols is not likely to be more strongly associated with an extensive risk of TF after 5-FU CRT+/− adjuvant chemotherapy. [ABSTRACT FROM AUTHOR]

Published
2024
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27. Inflammatory fibroblasts mediate resistance to neoadjuvant therapy in rectal cancer

Author

Nicolas, Adele M., Pesic, Marina, Engel, Esther, Ziegler, Paul K., Diefenhardt, Markus, Kennel, Kilian B., Buettner, Florian, Conche, Claire, Petrocelli, Valentina, Elwakeel, Eiman, Weigert, Andreas, Zinoveva, Anna, Fleischmann, Maximilian, Häupl, Björn, Karakütük, Cem, Bohnenberger, Hanibal, Mosa, Mohammed H., Kaderali, Lars, Gaedcke, Jochen, Ghadimi, Michael, Rödel, Franz, Arkan, Melek C., Oellerich, Thomas, Rödel, Claus, Fokas, Emmanouil, and Greten, Florian R.

Published
2022
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28. Analyses of molecular subtypes and their association to mechanisms of radioresistance in patients with HPV-negative HNSCC treated by postoperative radiochemotherapy

Author

Patil, Shivaprasad, Tawk, Bouchra, Grosser, Marianne, Lohaus, Fabian, Gudziol, Volker, Kemper, Max, Nowak, Alexander, Haim, Dominik, Tinhofer, Inge, Budach, Volker, Guberina, Maja, Stuschke, Martin, Balermpas, Panagiotis, Rödel, Claus, Schäfer, Henning, Grosu, Anca-Ligia, Abdollahi, Amir, Debus, Jürgen, Ganswindt, Ute, Belka, Claus, Pigorsch, Steffi, Combs, Stephanie E., Boeke, Simon, Zips, Daniel, Baretton, Gustavo B., Baumann, Michael, Krause, Mechthild, Löck, Steffen, and Linge, Annett

Published
2022
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30. Arbeitsgruppen zu kolorektalen Tumoren der AIO, der ACO und der ARO – „past, present, and future“

Author

Hofheinz, Ralf, Arnold, Dirk, Fichtner-Feigl, Stefan, Fokas, Emmanouil, Folprecht, Gunnar, Geissler, Michael, Ghadimi, Michael, Hegewisch-Becker, Susanne, Heinemann, Volker, Kasper-Virchow, Stefan, Kubicka, Stefan, Modest, Dominik Paul, Piso, Pompilio, Reinacher-Schick, Anke, Rödel, Claus-Michael, Seufferlein, Thomas, Stein, Alexander, and Stintzing, Sebastian

Published
2022
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37. International consensus recommendations on key outcome measures for organ preservation after (chemo)radiotherapy in patients with rectal cancer

Author

Fokas, Emmanouil, Appelt, Ane, Glynne-Jones, Robert, Beets, Geerard, Perez, Rodrigo, Garcia-Aguilar, Julio, Rullier, Eric, Joshua Smith, J., Marijnen, Corrie, Peters, Femke P., van der Valk, Maxine, Beets-Tan, Regina, Myint, Arthur S., Gerard, Jean-Pierre, Bach, Simon P., Ghadimi, Michael, Hofheinz, Ralf D., Bujko, Krzysztof, Gani, Cihan, Haustermans, Karin, Minsky, Bruce D., Ludmir, Ethan, West, Nicholas P., Gambacorta, Maria A., Valentini, Vincenzo, Buyse, Marc, Renehan, Andrew G., Gilbert, Alexandra, Sebag-Montefiore, David, and Rödel, Claus

Published
2021
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42. Correction to: Value of PET imaging for radiation therapy

Author

Lapa, Constantin, Nestle, Ursula, Albert, Nathalie L., Baues, Christian, Beer, Ambros, Buck, Andreas, Budach, Volker, Bütof, Rebecca, Combs, Stephanie E., Derlin, Thorsten, Eiber, Matthias, Fendler, Wolfgang P., Furth, Christian, Gani, Cihan, Gkika, Eleni, Grosu, Anca-L., Henkenberens, Christoph, Ilhan, Harun, Löck, Steffen, Marnitz-Schulze, Simone, Miederer, Matthias, Mix, Michael, Nicolay, Nils H., Niyazi, Maximilian, Pöttgen, Christoph, Rödel, Claus M., Schatka, Imke, Schwarzenboeck, Sarah M., Todica, Andrei S., Weber, Wolfgang, Wegen, Simone, Wiegel, Thomas, Zamboglou, Constantinos, Zips, Daniel, Zöphel, Klaus, Zschaeck, Sebastian, Thorwarth, Daniela, and Troost, Esther G. C.

Published
2022
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43. Quality of life in rectal cancer patients with or without oxaliplatin in the randomised CAO/ARO/AIO-04 phase 3 trial

Author

Kosmala, Rebekka, Fokas, Emmanouil, Flentje, Michael, Sauer, Rolf, Liersch, Torsten, Graeven, Ullrich, Fietkau, Rainer, Hohenberger, Werner, Arnold, Dirk, Hofheinz, Ralf-Dieter, Ghadimi, Michael, Ströbel, Philipp, Staib, Ludger, Grabenbauer, Gerhard G., Folprecht, Gunnar, Kirste, Simon, Uter, Wolfgang, Gall, Christine, Rödel, Claus, and Polat, Bülent

Published
2021
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47. De-intensification of postoperative radiotherapy in head and neck cancer irrespective of human papillomavirus status--results of a prospective multicenter phase II trial (DIREKHT Trial).

Author

Haderlein, Marlen, von der Grün, Jens, Balermpas, Panagiotis, Rödel, Claus, Hautmann, Matthias G., Steger, Felix, Bohr, Christopher, Hehr, Thomas, Stromberger, Carmen, Budach, Volker, Schymalla, Markus, Engenhart-Cabillic, Rita, Kocik, Lukas, Geinitz, Hans, Nestle, Ursula, Klautke, Gunter, Scherl, Claudia, Gall, Christine, Frey, Benjamin, and Schubert, Philipp

Subjects
HEAD & neck cancer, HUMAN papillomavirus, LYMPHATIC metastasis, SQUAMOUS cell carcinoma, SURGICAL margin
Abstract

Background: Current standard treatment concepts in head and neck squamous cell carcinoma (HNSCC) are based on former studies using 2D and 3D treatment plans. However, modern radiation techniques allow for a more precise and individual dose application. Therefore, in a clearly defined patient population, de-intensified risk-adapted radiation is investigated. Methods: Patients with newly diagnosed HNSCC after surgery (with resection margins ≥1mmand cM0) with the following tumor stages (TNM 7th Edition) were eligible for the study: oral cavity, oropharynx, or larynx: pT1-3, pN0-pN2b; hypopharynx: pT1-2, pN1. The patients should have either a low risk of local recurrence [≤pT2, resection margin ≥5 mm, no peritumoral lymphangiosis (L0), and no perineural invasion] or contralateral lymph node metastasis (≤3 ipsilateral lymph node metastases, in case of well-lateralized oropharyngeal or oral cavity cancer contralateral cN0, otherwise pN0). Patients were assigned to three different treatment regimes with reduction of the treated volume, radiation dose, or both, according to tumor stage and results of surgery performed. The primary objective was to show an LRR of <10% after 2 years. Findings: A total of 150 patients were enrolled. Tumor localizations were as follows: n = 53 (35.3%), oral cavity; n = 94 (62.7%), oropharynx (82% HPV-positive); n = 2 (1.3%), hypopharynx; and n = 1 (0.7%), larynx. A total of 61 patients (41.0%) were stage IVA, 81 (54.0%) were stage III, and 8 (5.3%) were stage II. Median followup was 36months. Cumulative incidence of 2y-LRR was 5.6% (95% CI: 1.7%-9.2%) in the whole study population and 14.1% (95% CI: 3.8%-23.2%) in patients with oral cavity cancer. Cumulative incidence of 2y-LRR in non-irradiated or dose-reduced regions was 3.5% (95% CI: 0.4%-6.5%). After 2 years, disease-free survival was 92% (95% CI: 87%-96%) and overall survival was 94% (95% CI: 90%-98%) for the complete study cohort. Acute III° toxicity was as follows: dysphagia, 30%; xerostomia, 7%; mucositis, 19%; and dermatitis, 4%. Dysphagia and xerostomia decrease over time. After 27 months, late dysphagia III° and xerostomia II° were 1% and 9%, respectively. Interpretation: The study met its primary objective. De-intensification of postoperative radiotherapy irrespective of HPV status in a predefined patient population is associated with a favorable toxicity profile without compromising LRR. In an unplanned subgroup analysis, a significantly increased risk of LRR was observed in patients with oral cavity cancer. In these patients, de-intensified radiotherapy should be applied with caution. [ABSTRACT FROM AUTHOR]

Published
2024
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50. Progression-free survival is a suboptimal predictor for overall survival among metastatic solid tumour clinical trials

Author

Pasalic, Dario, McGinnis, Gwendolyn J., Fuller, C. David, Grossberg, Aaron J., Verma, Vivek, Mainwaring, Walker, Miller, Austin B., Lin, Timothy A., Jethanandani, Amit, Espinoza, Andres F., Diefenhardt, Markus, Das, Prajnan, Subbiah, Vivek, Subbiah, Ishwaria M., Jagsi, Reshma, Garden, Adam S., Fokas, Emmanouil, Rödel, Claus, Thomas, Charles R., Jr., Minsky, Bruce D., and Ludmir, Ethan B.

Published
2020
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