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2. Hypofractionated (2.75 Gy per fraction) versus Conventionally Fractionated Primary Radiotherapy for T2N0M0 Carcinoma of the Glottis.

Author

Kovarik, Josef, Kelly, Charles, Cunnell, Michelle, Jamil, Fatima, and Iqbal, Muhammad Shahid

Subjects
GLOTTIS, INTENSITY modulated radiotherapy, RADIOTHERAPY, NASOENTERAL tubes, SQUAMOUS cell carcinoma
Abstract

Introduction Radiotherapy provides excellent outcome in early stage glottic cancer; however, the optimal radiotherapy dose fractionation remains unknown. Objective To investigate the outcome of patients with T2N0M0 treated with either hypofractionated (HypoFxn) or conventionally fractionated radical (ConFxn) radiotherapy. Methods According to our institutional protocol, patients with T2N0M0 glottic cancer can be treated either with ConfFxn or HypoFxn radiotherapy, as per clinician's and patient's choice, following shared decision making discussing the advantages and disadvantages of both modalities. A total of 77 patients with T2N0M0 squamous cell carcinoma of glottis treated with either HypoFxn 55Gy in 20 fractions (n = 19) or ConFxn 63 to 65Gy in 30 fractions (n = 58) were included. Results With median follow-up of 3.4 years, there was no significant difference in disease-free survival (median: HypoFxn = 65.2 months, and ConFxn = 75.3 months; p = 0.874), local recurrence free survival rates (median: HypoFxn = 78.8 months vs. ConFxn = 81.2 months; p = 0.274), and overall survival (median: HypoFxn = 65.9 months vs. ConFxn = 67.7 months; p = 0.532). Elective neck irradiation was given to 43 patients, all in the ConFxn group, and this was associated with poorer local control (p = 0.027). The use of radiotherapy modality, three-dimensional conformal radiotherapy (3DRT) versus intensity modulated radiotherapy (IMRT), was not a prognostic factor (p = 0.36). In the HypoFxn group, grade III acute dysphagia requiring nasogastric tube was 16%, compared with 25% in the ConFxn group (p = 0.446). Conclusion HypoFxn radiotherapy provides a comparable treatment outcome with acceptable toxicity. The addition of prophylactic irradiation of the neck lymph nodes has no impact on regional control. [ABSTRACT FROM AUTHOR]

Published
2023
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5. Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma: A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial

Author

Jones, Robert P, Psarelli, Eftychia-Eirini, Jackson, Richard, Ghaneh, Paula, Halloran, Christopher M, Palmer, Daniel H, Campbell, Fiona, Valle, Juan W, Faluyi, Olusola, O'Reilly, Derek A, Cunningham, David, Wadsley, Jonathan, Darby, Suzanne, Meyer, Tim, Gillmore, Roopinder, Anthoney, Alan, Lind, Pehr, Glimelius, Bengt, Falk, Stephen, Izbicki, Jakob R, Middleton, Gary William, Cummins, Sebastian, Ross, Paul J, Wasan, Harpreet, McDonald, Alec, Crosby, Tom, Ting, Yuk, Patel, Kinnari, Sherriff, David, Soomal, Rubin, Borg, David, Sothi, Sharmila, Hammel, Pascal, Lerch, Markus M, Mayerle, Julia, Tjaden, Christine, Strobel, Oliver, Hackert, Thilo, Buchler, Markus W, Neoptolemos, John P, Hill, Mark, Corrie, Pippa, Hickish, Tamas, Napier, Mark, Slater, Sarah, Valle, Juan, Shablak, Alaaeldin, Cunnell, Michelle, Guimbaud, Rosine, Roques, Tom, Iveson, Tim, Jamil, Arshad, Robinson, Angus, Garcia-Alonso, Angel, Chang, David, Tsang, David, Wadd, Nick, Wall, Lucy, Nielsen, Niels Hilmer, Lerch, Markus, Mehta, Ajay, Sivaramalingam, Muthiah, Fyfe, David, Osborne, Richard, Blesing, Claire, Bulusu, Venkata Ramesh, Rathbone, Emma, Seitz, Jean-Francois, Beaumont, Erica, Dernedde, Ulrike, McAdam, Karen, Dimopoulos, Prokopios, Cominos, Mathilda, Askill, Colin, Piwowar, Andrzej, Bachet, Jean-Baptiste, Sumpter, Kate, Raouf, Sherif, Nicoll, Jonathan, Rees, Charlotte, Dhinakaran, Kathirvelu, Haux, Johan, Bengrine-Lefevre, Leila, Terrebonne, Eric, Shankland, Catherine, Palmer, Cheryl, Medley, Louise, Toy, Elizabeth, Kaur, Jasvinder, Gupta, Kamalnayan, Cheeseman, Sue, Patterson, Daniel, Candish, Charles, Thompson, Joyce, Coxon, Fareeda, Connolly, Caroline, McPhail, Neil, Williams, Rachel, Flygare, Petra, Elmlund, Mattias, Artru, Pascal, Millat, Bertrand, and Canc, European Study Grp Pancreatic

Subjects
medicine.medical_specialty, Chemotherapy, Randomization, business.industry, medicine.medical_treatment, 030230 surgery, medicine.disease, Gastroenterology, Gemcitabine, law.invention, Capecitabine, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, 030220 oncology & carcinogenesis, Internal medicine, Pancreatic cancer, medicine, Carcinoma, Surgery, Prospective cohort study, business, medicine.drug
Abstract

Importance The patterns of disease recurrence after resection of pancreatic ductal adenocarcinoma with adjuvant chemotherapy remain unclear. Objective To define patterns of recurrence after adjuvant chemotherapy and the association with survival. Design, Setting, and Participants Prospectively collected data from the phase 3 European Study Group for Pancreatic Cancer 4 adjuvant clinical trial, an international multicenter study. The study included 730 patients who had resection and adjuvant chemotherapy for pancreatic cancer. Data were analyzed between July 2017 and May 2019. Interventions Randomization to adjuvant gemcitabine or gemcitabine plus capecitabine. Main Outcomes and Measures Overall survival, recurrence, and sites of recurrence. Results Of the 730 patients, median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43%). The median follow-up time from randomization was 43.2 months (95% CI, 39.7-45.5 months), with overall survival from time of surgery of 27.9 months (95% CI, 24.8-29.9 months) with gemcitabine and 30.2 months (95% CI, 25.8-33.5 months) with the combination (HR, 0.81; 95% CI, 0.68-0.98;P = .03). The 5-year survival estimates were 17.1% (95% CI, 11.6%-23.5%) and 28.0% (22.0%-34.3%), respectively. Recurrence occurred in 479 patients (65.6%); another 78 patients (10.7%) died without recurrence. Local recurrence occurred at a median of 11.63 months (95% CI, 10.05-12.19 months), significantly different from those with distant recurrence with a median of 9.49 months (95% CI, 8.44-10.71 months) (HR, 1.21; 95% CI, 1.01-1.45;P = .04). Following recurrence, the median survival was 9.36 months (95% CI, 8.08-10.48 months) for local recurrence and 8.94 months (95% CI, 7.82-11.17 months) with distant recurrence (HR, 0.89; 95% CI, 0.73-1.09;P = .27). The median overall survival of patients with distant-only recurrence (23.03 months; 95% CI, 19.55-25.85 months) or local with distant recurrence (23.82 months; 95% CI, 17.48-28.32 months) was not significantly different from those with only local recurrence (24.83 months; 95% CI, 22.96-27.63 months) (P = .85 andP = .35, respectively). Gemcitabine plus capecitabine had a 21% reduction of death following recurrence compared with monotherapy (HR, 0.79; 95% CI, 0.64-0.98;P = .03). Conclusions and Relevance There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence. Pancreatic cancer behaves as a systemic disease requiring effective systemic therapy after resection. Trial Registration ClinicalTrials.gov identifier:NCT00058201, EudraCT 2007-004299-38, and ISRCTN 96397434.

Published
2019

6. Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma : A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial

Author

Jones, Robert P., Psarelli, Eftychia-Eirini, Jackson, Richard, Ghaneh, Paula, Halloran, Christopher M., Palmer, Daniel H., Campbell, Fiona, Valle, Juan W., Faluyi, Olusola, O'Reilly, Derek A., Cunningham, David, Wadsley, Jonathan, Darby, Suzanne, Meyer, Tim, Gillmore, Roopinder, Anthoney, Alan, Lind, Pehr, Glimelius, Bengt, Falk, Stephen, Izbicki, Jakob R., Middleton, Gary William, Cummins, Sebastian, Ross, Paul J., Wasan, Harpreet, McDonald, Alec, Crosby, Tom, Ting, Yuk, Patel, Kinnari, Sherriff, David, Soomal, Rubin, Borg, David, Sothi, Sharmila, Hammel, Pascal, Lerch, Markus M., Mayerle, Julia, Tjaden, Christine, Strobel, Oliver, Hackert, Thilo, Buchler, Markus W., Neoptolemos, John P., Hill, Mark, Corrie, Pippa, Hickish, Tamas, Napier, Mark, Slater, Sarah, Valle, Juan, Shablak, Alaaeldin, Cunnell, Michelle, Guimbaud, Rosine, Roques, Tom, Iveson, Tim, Jamil, Arshad, Robinson, Angus, Garcia-Alonso, Angel, Chang, David, Tsang, David, Wadd, Nick, Wall, Lucy, Nielsen, Niels Hilmer, Lerch, Markus, Mehta, Ajay, Sivaramalingam, Muthiah, Fyfe, David, Osborne, Richard, Blesing, Claire, Bulusu, Venkata Ramesh, Rathbone, Emma, Seitz, Jean-Francois, Beaumont, Erica, Dernedde, Ulrike, McAdam, Karen, Dimopoulos, Prokopios, Cominos, Mathilda, Askill, Colin, Piwowar, Andrzej, Bachet, Jean-Baptiste, Sumpter, Kate, Raouf, Sherif, Nicoll, Jonathan, Rees, Charlotte, Dhinakaran, Kathirvelu, Haux, Johan, Bengrine-Lefevre, Leila, Terrebonne, Eric, Shankland, Catherine, Palmer, Cheryl, Medley, Louise, Toy, Elizabeth, Kaur, Jasvinder, Gupta, Kamalnayan, Cheeseman, Sue, Patterson, Daniel, Candish, Charles, Thompson, Joyce, Coxon, Fareeda, Connolly, Caroline, McPhail, Neil, Williams, Rachel, Flygare, Petra, Elmlund, Mattias, Artru, Pascal, Millat, Bertrand, Jones, Robert P., Psarelli, Eftychia-Eirini, Jackson, Richard, Ghaneh, Paula, Halloran, Christopher M., Palmer, Daniel H., Campbell, Fiona, Valle, Juan W., Faluyi, Olusola, O'Reilly, Derek A., Cunningham, David, Wadsley, Jonathan, Darby, Suzanne, Meyer, Tim, Gillmore, Roopinder, Anthoney, Alan, Lind, Pehr, Glimelius, Bengt, Falk, Stephen, Izbicki, Jakob R., Middleton, Gary William, Cummins, Sebastian, Ross, Paul J., Wasan, Harpreet, McDonald, Alec, Crosby, Tom, Ting, Yuk, Patel, Kinnari, Sherriff, David, Soomal, Rubin, Borg, David, Sothi, Sharmila, Hammel, Pascal, Lerch, Markus M., Mayerle, Julia, Tjaden, Christine, Strobel, Oliver, Hackert, Thilo, Buchler, Markus W., Neoptolemos, John P., Hill, Mark, Corrie, Pippa, Hickish, Tamas, Napier, Mark, Slater, Sarah, Valle, Juan, Shablak, Alaaeldin, Cunnell, Michelle, Guimbaud, Rosine, Roques, Tom, Iveson, Tim, Jamil, Arshad, Robinson, Angus, Garcia-Alonso, Angel, Chang, David, Tsang, David, Wadd, Nick, Wall, Lucy, Nielsen, Niels Hilmer, Lerch, Markus, Mehta, Ajay, Sivaramalingam, Muthiah, Fyfe, David, Osborne, Richard, Blesing, Claire, Bulusu, Venkata Ramesh, Rathbone, Emma, Seitz, Jean-Francois, Beaumont, Erica, Dernedde, Ulrike, McAdam, Karen, Dimopoulos, Prokopios, Cominos, Mathilda, Askill, Colin, Piwowar, Andrzej, Bachet, Jean-Baptiste, Sumpter, Kate, Raouf, Sherif, Nicoll, Jonathan, Rees, Charlotte, Dhinakaran, Kathirvelu, Haux, Johan, Bengrine-Lefevre, Leila, Terrebonne, Eric, Shankland, Catherine, Palmer, Cheryl, Medley, Louise, Toy, Elizabeth, Kaur, Jasvinder, Gupta, Kamalnayan, Cheeseman, Sue, Patterson, Daniel, Candish, Charles, Thompson, Joyce, Coxon, Fareeda, Connolly, Caroline, McPhail, Neil, Williams, Rachel, Flygare, Petra, Elmlund, Mattias, Artru, Pascal, and Millat, Bertrand

Abstract

Importance: The patterns of disease recurrence after resection of pancreatic ductal adenocarcinoma with adjuvant chemotherapy remain unclear. Objective: To define patterns of recurrence after adjuvant chemotherapy and the association with survival. Design, Setting, and Participants: Prospectively collected data from the phase 3 European Study Group for Pancreatic Cancer 4 adjuvant clinical trial, an international multicenter study. The study included 730 patients who had resection and adjuvant chemotherapy for pancreatic cancer. Data were analyzed between July 2017 and May 2019. Interventions: Randomization to adjuvant gemcitabine or gemcitabine plus capecitabine. Main Outcomes and Measures: Overall survival, recurrence, and sites of recurrence. Results: Of the 730 patients, median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43%). The median follow-up time from randomization was 43.2 months (95% CI, 39.7-45.5 months), with overall survival from time of surgery of 27.9 months (95% CI, 24.8-29.9 months) with gemcitabine and 30.2 months (95% CI, 25.8-33.5 months) with the combination (HR, 0.81; 95% CI, 0.68-0.98; P=.03). The 5-year survival estimates were 17.1% (95% CI, 11.6%-23.5%) and 28.0% (22.0%-34.3%), respectively. Recurrence occurred in 479 patients (65.6%); another 78 patients (10.7%) died without recurrence. Local recurrence occurred at a median of 11.63 months (95% CI, 10.05-12.19 months), significantly different from those with distant recurrence with a median of 9.49 months (95% CI, 8.44-10.71 months) (HR, 1.21; 95% CI, 1.01-1.45; P=.04). Following recurrence, the median survival was 9.36 months (95% CI, 8.08-10.48 months) for local recurrence and 8.94 months (95% CI, 7.82-11.17 months) with distant recurrence (HR, 0.89; 95% CI, 0.73-1.09; P=.27). The median overall survival of patients with distant-only recurrence (23.03 months; 95% CI, 19.55-25.85 months) or local with distant recurrence (23.82 months; 95% CI, 17.48-28.32

Published
2019
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7. Targeting gp100 and TRP-2 with a DNA vaccine: Incorporating T cell epitopes with a human IgG1 antibody induces potent T cell responses that are associated with favourable clinical outcome in a phase I/II trial

Author

Patel, Poulam M., primary, Ottensmeier, Christian H., additional, Mulatero, Clive, additional, Lorigan, Paul, additional, Plummer, Ruth, additional, Pandha, Hardev, additional, Elsheikh, Somaia, additional, Hadjimichael, Efthymios, additional, Villasanti, Naty, additional, Adams, Sally E., additional, Cunnell, Michelle, additional, Metheringham, Rachael L., additional, Brentville, Victoria A., additional, Machado, Lee, additional, Daniels, Ian, additional, Gijon, Mohamed, additional, Hannaman, Drew, additional, and Durrant, Lindy G., additional

Published
2018
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8. An adjuvant clinical trial of SCIB1, a DNA vaccine that targets dendritic cells in vivo, in fully resected melanoma patients.

Author

Patel, Poulam M., primary, Ottensmeier, Christian, additional, Mulatero, Clive, additional, Lorigan, Paul, additional, Plummer, Ruth, additional, Hannaman, Drew, additional, Cunnell, Michelle, additional, Metheringham, Rachael, additional, Brentville, Victoria, additional, Daniels, Ian, additional, Machado, Lee, additional, and Durrant, Linda G, additional

Published
2015
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9. Phase I trial of ImmunoBody in melanoma patients.

Author

Patel, Poulam M., primary, Durrant, Lindy G, additional, Ottensmeier, Christian, additional, Mulatero, Clive, additional, Lorigan, Paul, additional, Plummer, Ruth, additional, Cunnell, Michelle, additional, Metheringham, Rachael, additional, Brentville, Victoria, additional, Machado, Lee, additional, Daniels, Ian, additional, and Hannaman, Drew, additional

Published
2014
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