scholarly journals Randomised clinical trial on 7-days-a-week postoperative radiotherapy vs. concurrent postoperative radio-chemotherapy in locally advanced cancer of the oral cavity/oropharynx

2020 ◽  
Vol 93 (1116) ◽  
pp. 20200288
Author(s):  
Grzegorz Wozniak ◽  
Maciej Misiołek ◽  
Adam Idasiak ◽  
Iwona Dębosz-Suwińska ◽  
Magdalena Jaworska ◽  
...  

Objective: To compare the efficacy and tolerance of 7-days-a-week accelerated postoperative radiotherapy (p-CAIR) vs postoperative radio-chemotherapy (p-RTCT) Methods: Between September 2007 and October 2013, 111 patients were enrolled and randomly assigned to receive 63 Gy in 1.8 Gy fractions 7-days-a-week (n = 57, p-CAIR) or 63 Gy in 1.8 Gy fractions 5-days-a-week with concurrent cisplatin 80–100 mg per square meter of body-surface area on days 1, 22 and 43 of the radiotherapy course (p-RTCT). It represents approximately 40% of the intended trial size, that was closed prematurely due to slowing accrual. Only high-risk patients with squamous cell cancer of the oropharynx/oral cavity, considered fit for concurrent treatment were enrolled. Results: The rate of locoregional control (LRC) did not differ significantly between treatment arms (p = 0.18, HR = 0.56), 5 year LRC tended, however, to favour p-RTCT (81%) vs p-CAIR (62%). There was no difference in overall survival between treatment arms (p = 0.90, HR = 1.03). The incidence and severity of acute mucosal reactions and late reactions did not differ significantly between treatment arms. Haematological toxicity of p-RTCT was, however, considerably increased compared to p-CAIR Conclusion: Concurrent postoperative RTCT tended to improve locoregional control rate as compared to p-CAIR. This, however, did not transferred into improved overall survival. Postoperative RTCT was associated with a substantial increase in haematological toxicity that negatively affected treatment compliance in this arm. Advances in knowledge: To our knowledge, this is the first trial that compares accelerated radiotherapy and radio-chemotherapy in postoperative treatment for oralcavity/oropharyngeal cancer

2003 ◽  
Vol 21 (2) ◽  
pp. 327-333 ◽  
Author(s):  
Lisa Licitra ◽  
Cesare Grandi ◽  
Marco Guzzo ◽  
Luigi Mariani ◽  
Salvatore Lo Vullo ◽  
...  

Purpose: Prognosis of patients with advanced oral cavity cancer is worth improving. Chemotherapy has been reported to be especially active in oral cavity tumors. Here we repeat the results of a randomized, multicenter trial enrolling patients with a resectable, stage T2–T4 (> 3 cm), N0–N2, M0 untreated, squamous cell carcinoma of the oral cavity. Patients and Methods: Patients were randomly assigned to three cycles of cisplatin and fluorouracil followed by surgery (chemotherapy arm) or surgery alone (control arm). In both arms, postoperative radiotherapy was reserved to high-risk patients, and surgery was modulated depending on the tumor’s closeness to the mandible. Patients’ accrual was opened in 1989 and closed in 1999. It included 195 patients. Results: In the chemotherapy arm, three toxic deaths were recorded. No significant difference in overall survival was found. Five-year overall survival was, for both arms, 55%. Postoperative radiotherapy was administered in 33% of patients in the chemotherapy arm, versus 46% in the control arm. A mandible resection was performed in 52% of patients in the control arm, versus 31% in the chemotherapy arm. Conclusion: The addition of primary chemotherapy to standard surgery was unable to improve survival. However, in this study, primary chemotherapy seemed to play a role in reducing the number of patients who needed to undergo mandibulectomy and/or radiation therapy. Variations in the criteria used to select patients for these treatment options may make it difficult to generalize these results, but there appears to be room for using preoperative chemotherapy to spare demolitive surgery and/or radiation therapy in patients with advanced, resectable oral cavity cancer.


2021 ◽  
Author(s):  
Michela Buglione ◽  
Daniela Alterio ◽  
Marta Maddalo ◽  
Diana Greco ◽  
marianna alessandra gerardi ◽  
...  

Abstract Background Radio-chemotherapy with CDDP is the standard for H&N squamous cell cancer. CDDP 100mg/m2/q3 is the standard; alternative schedules are used to reduce toxicity, mostly 40mg/m2/q1. Methods Patients were treated from 1/2010 to 1/2017 in two Radiation Oncology Centres. Propensity score analysis (PS) was retrospectively used to compare these two schedules. Results Patients analyzed were 166. Most (114/166) had 1w-CDDP while 52 had 3w-CDDP. In the 3w-CDDP group, patients were younger and with better performance status; disease extent was smaller and nodal involvement was more common than in the 1w-CDDP. Acute toxicity was similar in the groups. Treatment compliance was lower in the w-CCDP. OS before PS was better for female, for oropharyngeal disease and for 3w-CDDP group. After PS, survival was not related to the CDDP schedule. Conclusions 3w-CDDP remains the standard for fit patients, weekly schedule could be safely used in selected patients.


Author(s):  
Patrícia S. Gomes ◽  
Eduardo Breda ◽  
Eurico Monteiro

<p class="abstract"><strong>Background:</strong> Delays in cancer diagnosis and treatment are usually associated with patient anxiety, tumour progression and lower survival. This study aims to analyse the potential impact of rescheduling adjuvant treatments on survival outcome of patients with locally advanced oropharyngeal squamous cell cancer (OPSCC).</p><p class="abstract"><strong>Methods:</strong> A retrospective review of medical records comprising all patients with advanced oropharyngeal cancer who underwent primary surgery and postoperative radiotherapy (PORT) in a Tertiary Oncologic Centre from 2011 to 2016 was performed.</p><p class="abstract"><strong>Results:</strong> 63 patients with a male/female ratio of 8:1 and mean age of 57.5±9.6 years were enrolled. Patients waited a mean of 47.2±18.2 days from diagnosis to surgery and a median of 61 days from surgery to radiotherapy. Median radiotherapy duration was 43 days and the mean package time was 104.5±21.0 days. Analysis of these parameters has shown decreasing intervals from 2011 to 2016, although this was only significant for duration of PORT (p=0.022). Longer time span from surgery to PORT and PORT duration were predictive of superior package times (p&lt;0.001). Five-year overall survival and disease-free survival was 63.8% and 64.8% respectively with no statistically significant impact of waiting times on clinical outcome.</p><p class="abstract"><strong>Conclusions:</strong> Despite presenting favourable long-term outcomes, patients with locally advanced OPSCC have experienced longer waiting times than recommended. Waiting times were not prognostic factors in this condition, although efforts to reduce it might provide superior quality of care. Future studies assessing the factors involved in treatment delays might provide means to offer timely treatments.  </p><p class="abstract"> </p><p> </p>


2021 ◽  
Author(s):  
Xiaohan Lin ◽  
Biyu Chen ◽  
Wei Zheng ◽  
Shugang Yang ◽  
Guangwei Zhu ◽  
...  

Abstract Background: The objective of this study was to assess the clinical efficacy of radiotherapy combined with surgery for locally advanced gastric signet-ring-cell carcinoma (GSRCC). Methods: Clinical data of patients with locally advanced GSRCC diagnosed by postoperative pathology from 2000-2016 were collected from the US Surveillance, Epidemiology and End Results (SEER) database. All the enrolled patients were divided into three groups according to treatment type: surgery alone (S; N=727), surgery with preoperative radiotherapy (RT+S; N=138), surgery with postoperative radiotherapy (S+RT; N=548). Results: The median overall survival (OS) time in S, RT+S and S+RT group was 19, 26 and 33 months, respectively; the overall survival (OS) rate was 19.5%, 26.9% and 34.0%, respectively; the median cancer-specific survival (CSS) time was 29, 31 and 43 months, respectively; and the CSS rate was 32,4%, 35.3% and 43.6%, respectively. After performing propensity score matching (PSM), it was found that the OS rate was significantly lower in S group than in RT+S or S+RT group (all P<0.05) and the CSS rate was lower in the SA group than in the S+RT group (P<0.0001) while there was no significant difference between S and RT+S groups. The OS and CSS were not significantly different between RT+S and S+RT groups. Cox multivariate analysis showed that radiotherapy was an independent prognostic factor for OS and CSS of locally advanced GSRCC.Conclusions: Compared to surgery alone, surgery combined with preoperative or postoperative radiotherapy is beneficial to the long-term survival of patients with locally advanced GSRCC.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17024-e17024
Author(s):  
Rakesh Roy ◽  
Indranil Chatterjee ◽  
Indranil Chatterjee

e17024 Background: In locally advanced squamous cell carcinoma of the oral cavity, neoadjuvant chemotherapy induces a high response rate that may facilitate definitive surgery or radiotherapy. Patients have an acceptable long-term survival.A strategy was developed in a tertiary care cancer hospital in India to treat patients with locally advanced oral cancers with induction CT followed by surgery if possible.In our centre selection of neoadjuvant regimens were based on following criteria: age, performance status, financial status, accessibility, comorbid illness, and lab parameters. Methods: 32 patients with locally advanced cancers of the oral cavity and inoperable upfront were selected for neoadjuvant chemotherapy. All were male patients, age ranging from 32 – 65 years, with a performance status ECOG 0-1. All had been tobacco users in some form and hailed from east and northeast parts of India. HPV data were unavailable. 2 patients had controlled diabetes. No other comorbidity was found. 20 patients got DCF (docetaxel, 5FU, cisplatin), 8 patients received PCF (paclitaxel, 5FU, cisplatin), 4 patients received PC (paclitaxel, carboplatin). 20-hr infusional 5FU daily was given over a period of 3 days in both the DCF and PCF arms unlike the 5 day infusion. All received growth factors as primary prophylaxis. Results: Patients who received DCF showed the best response followed by PCF and finally PC. Complete response (CR) was found in 6 patients, all of whom received DCF. All underwent surgery. Amongst toxicity neutropenia was highest with DCF arm but none developed febrile neutropenia. Patients exposed to 5FU had grade 1-2 diarrhoea in 90 % cases. No grade 3-4 mucositis were recorded. Diabetic patients who received PC and PCF and did not experience additional neurotoxicity. Dose reduction or modification was required in one patient who received DCF. Conclusions: Neoadjuvant chemotherapy is an useful treatment option for locally advanced cancers of the oral cavity. DCF regimen is most effective and well tolerated in Indian patients. Judicious selection of patient is necessary.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS4158-TPS4158 ◽  
Author(s):  
Markus Hermann Moehler ◽  
Ingo Ringshausen ◽  
Ralf Hofheinz ◽  
Salah-Eddin Al-Batran ◽  
Lothar Mueller ◽  
...  

TPS4158 Background: More than 50% of pts with esophageal cancer have locally advanced or metastatic disease at the time of initial diagnosis. For this group chemotherapy is increasingly used intending local and distant tumor control, improvement of quality of life (QoL) and longer survival. Previous data suggested that EGFR-targeting antibodies may be safely combined with cisplatin and 5-FU, and in addition may increase the efficacy of the standard cisplatin/5-FU regimen [Lorenzen et al, Ann Oncol2009; 20(10): 1667-1673]. Methods: In this open-label, randomized (1:1), multicenter, multinational phase III trial pts with nonresectable, advanced or metastatic ESCC, not eligible for definitive radiochemotherapy, are included. Pts have measurable or non-measurable disease according to RECIST 1.1 and an ECOG PS 0-1. Previous chemotherapy of ESCC in the metastatic setting, concurrent radiotherapy involving target lesions and previous exposure to EGFR-targeted therapy are excluded. Pts receive either CTX (cisplatin 100 mg/m² on day 1 and 5-FU 1000 mg/m²/d on day 1-4) or CTX + P (9 mg/kg on day 1). Cycles are repeated every 3 weeks until progression of disease. Tumor assessment is performed every 9 weeks. The primary objective is to demonstrate superiority of CTX + P over CTX alone in terms of overall survival. Secondary endpoints are progression-free survival, 1-year survival, response rate, safety and tolerability, and QoL. A translational analysis in tumor tissue and serum samples is included. 300 pts are planned to be enrolled for a power of 90% to reject the null hypothesis in which the median overall survival in the control and experimental groups are 6 and 9 months, respectively. 18 pts have been enrolled to date. A Data Monitoring Board will review safety data after 40, 100 and 200 pts. The clinical trial registry number is NCT1627379. Clinical trial information: NCT01627379.


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