scholarly journals Standard-dose versus high-dose radiotherapy with concurrent chemotherapy in esophageal cancer: A prospective randomized study

2018 ◽  
Vol 07 (01) ◽  
pp. 27-30 ◽  
Author(s):  
Navin Nayan ◽  
M. Bhattacharyya ◽  
Vikas K. Jagtap ◽  
A. K. Kalita ◽  
R. Sunku ◽  
...  

Abstract Objective: The objective of this study is comparision of local and distant control rates with high-dose versus standard-dose radiotherapy along with concurrent chemotherapy in esophageal cancer – a prospective randomized study. Materials and Methods: Histologically proven Stage I–III patients with carcinoma esophagus were randomized into two groups. One group has been treated with standard-dose radiotherapy, i.e., a total dose of 50.4 Gy (1.8 Gy/day, 28#, 5 days/week). The other group (study arm) has received high-dose radiotherapy, i.e. a total dose of 64.8 Gy (1.8 Gy/day, 36#, 5 days/week). Both groups have received 2 cycles of 3 weekly concurrent chemotherapy (cisplatin 75 mg/m[2] on day 1 and 5-fluorouracil 750 mg/m[2] continuous intravenous infusion over 24 h on day 1–4). Follow-up response evaluation was done by both endoscopy and computed tomography scan after 6–8 weeks and after 2 months thereafter. Results: Out of a total of 28 patients, 68% showed a complete response, 14% showed partial response, and 18% patients developed progressive disease at first and subsequent follow up (median follow-up of 21 months). Among the complete response patients, rates were higher in high-dose group compared to standard-dose radiotherapy group (71% vs. 64%, P = 0.38). Treatment-related toxicities were acceptable in both groups. Conclusion: High-dose radiotherapy with concurrent chemotherapy seems to be more effective with acceptable toxicity in our study. However, further follow-up and large sample size may be required to validate the current study conclusion.

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7717-7717 ◽  
Author(s):  
R. Komaki ◽  
J. Moughan ◽  
D. Ettinger ◽  
G. Videtic ◽  
J. Bradley ◽  
...  

7717 Background: Accelerated fractionation proved beneficial in INT0096, but the total dose was low and local recurrence was high with higher acute grade (Gr.) 3+ esophagitis. RTOG 0239 was a phase II trial to improve local control and survival with LSCLC with acceptable acute Gr. 3+ esophagitis using accelerated high dose TRT and concurrent cisplatin/etoposide. This is the first report of acute Gr.3+ esophagitis and Gr.5 toxicities. Methods: Patients (pts) with LSCLC without pleural effusion, contralateral hilar or contralateral supraclavicular nodes and PS 0–1 were enrolled. TRT was given to large fields to 28.8 Gy at 1.8 Gy per fraction, 5 days per week for 16 fractions followed by BID with large field in AM, boost in PM, then off-cord boost BID for last 5 days, all at 1.8 Gy per fx for a total dose of 61.2 Gy in 34 fx in 5 weeks. Concurrent chemotherapy was started with TRT with cisplatin, 60 mg/m2 i.v. day 1; etoposide, 120 mg/m2 i.v. day 1; etoposide, 240 mg/m2 p.o. per day or 120 mg/m2 i.v. per day on days 2 or 3. Cycles were repeated q.3 wks during and for 2 cycles after TRT. Pts who have achieved complete response one month after completion of 4 cycles of chemotherapy were asked to participate in a prophylactic cranial irradiation (PCI) study. Common toxicity criteria (CTC) 2.0 was used for acute toxicity. Results: From 10/2003 to 5/2006, 72 pts were accrued. Median age was 63 yrs with 52% females. Survival data is still maturing. Acute toxicity information is available for 68 pts. Eleven pts (16%) experienced acute Gr. 3 and 1 pt (1%) had acute Gr. 4 esophagitis. 47 pts (69%) had grade 4 blood/bone marrow toxicities. There were 2 (3%) Gr. 5 toxicities reported [1 infection with neutropenia; 1 pulmonary (pneumonia)]. Conclusions: This accelerated high dose TRT with concurrent chemotherapy for LSCLC resulted in 17% acute Gr.3+ esophagitis compared to 27% with BID TRT with 45Gy in 3 weeks by INT0096. There were 3% grade 5 toxicities. This preliminary report suggests that RTOG-0239 has tolerable toxicity. The acute Gr3+ esophageal toxicity correlated with V20 and V40 will be presented. Pts continue to be followed for the primary endpoint of 2-year survival. No significant financial relationships to disclose.


2014 ◽  
Vol 44 (6) ◽  
pp. 534-540 ◽  
Author(s):  
Yang-Gun Suh ◽  
Ik Jae Lee ◽  
Wong Sub Koom ◽  
Jihye Cha ◽  
Jong Young Lee ◽  
...  

2019 ◽  
Vol 08 (03) ◽  
pp. 178-182
Author(s):  
R. Nanda ◽  
Aradhana Katke ◽  
N. Suneetha ◽  
B. Thejaswini ◽  
Tanvir Pasha ◽  
...  

Abstract Introduction: The chemotherapy schedules with cytotoxic dose or weekly regimes are still challenging, weighing the benefits versus toxicities. This prospective randomized study is an attempt to assess the efficacy of two schedules of cisplatin in management of locally advanced HNSCC. Objectives: The objectives of this study was to evaluate tolerance, tumour response and toxicities of concurrent chemoradiation with cisplatin in weekly and three weekly regimes. Methods: Locally advanced oropharyngeal squamous cell carcinoma patients fit for concurrent chemoradiation with cisplatin 40 mg/m2 (weekly) and 100 mg/m2 (3 weekly) were randomized to Arm A and B concurrently with radiotherapy of 70Gy/35frs/7 weeks. Statistical Analysis: Chi-square/Fisher Exact test has been used to find the significance of study parameters on categorical scale between the groups. The statistical software SPSS 15.0 was used. Results: Between December 2010 and January 2013, 60 patients were enrolled. The median cycles of cisplatin in Arm-A was 5 and 2 in Arm-B. The complete response of 80.9% vs 75% and partial response of 14.3% vs 12.5% was observed in both arms respectively. There was no statistical difference in acute radiation and hematological toxicities between the two groups. With median follow up of 28 months, the 2 and 5 years overall survival was 55% and 58%; 41.6% and 32.3% in arms A and B respectively. Conclusion: In our study of locally advanced oropharyngeal carcinoma treated with radical radiotherapy comparing concurrent chemotherapy with cisplatin weekly vs 3 weekly had no significant difference in overall response, complete response and acute toxicities.


Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 5116-5116
Author(s):  
Simona Bassi ◽  
Alessandra Alietti ◽  
Chiara Corsini ◽  
Federica Gigli ◽  
Paola Bertazzoni ◽  
...  

Abstract Mantle cell lymphoma (MCL) is an aggressive disease, currently incurable with standard-dose chemotherapy. Autologous cell transplantation (ASCT) is frequently considered a therapeutical approach in MCL, despite not generally being curative. In controlled studies upfront ASCT showed a significant event-free survival advantage, that might be improved by the addition of the anti-CD20 monoclonal-antibody (MoAb) (Rituximab®) in the myeloablative regimen. Based on these evidences, we prospectively analysed our patients (pts) affected by MCL, who received a continuous Rituximab administration in course on treatment. From May 2000 to the present we treated 22 pts with histological diagnosis of MCL, including 16 pts (73%) newly diagnosed. The majority were male (15/22) and the median age at diagnosis was 56 years old (range 35–66). Disease was stage III–IV: 21 pts with bone marrow involvement in 60%. Eleven pts presented extranodal involvement. The induction schedule included 2–4 CHOP-like regimen with MoAb (R-ACOD), followed by mobilization chemotherapy with cyclophosphamide, MoAb and G-CSF. Harvest was performed successfully in all pts with a median number of CD34-positive cells of 8.0 x 106/Kg (1.9–22.8 106/Kg). Subsequently the pts received 2 cycles of high-dose, cytarabine-based regimen with MoAb (R-ESHAP). Rituximab injections were given at standard dose (375 mg/mq). Before ASCT, 11 pts (50%) were in complete response (CR); in particularly 5 of them who were pretreated. Eight achieved partial response, while one was in progression. Two pts were not restaged. One patient did not undergo ASCT, because of serious pulmonary infection after high-dose cytarabine. In terms of conditioning regimen all pts received Rituximab (375 mg/mq), Melphalan (180mg/mq) in association with either Idarubicin (15mg/mq for 3 days) in 13 pts and or Novantrone (60 mg/mq for 1 day) in 8 pts. After stem cell reinfusion and G-CSF from Day +5, the median time to recovery (neutrophil counts >0.5x103) was 14 days (range 13–28 days) in the first regimen versus 10 days (range 8–11 days) in the more recent regimen. During aplasia the infection rate was low, as a matter of fact we observed just two episodes of pneumonia, that resolved at neutrophil recovery. No toxic death was reported. Response at 3 months after ASCT was evaluable in 19 patients (90%); one was lost at follow-up, while one has been transplanted one month ago. Seventy patients (80%) achieved complete response, maintained in 11 of them after a median time of 23 month (range 10–79) after ASCT; seven of them were in complete response before the transplant procedure. With a median time of 27 months (range 9–46 months) 7 patients progressed and 4 of these died because of lymphoma. Our study supports that ASCT can be considered a valid approach to induce high response rate. To enhance the ASCT outcomes, the addition of Rituximab can be considered a feasible approach associated with its “purging in vivo” effect. Long-term disease control might be reflected upon a plateau in the survival curve, but a randomised study and longer follow up is warranted.


2007 ◽  
Vol 177 (4S) ◽  
pp. 453-453 ◽  
Author(s):  
Ervin Kocjancic ◽  
Simone Crivellaro ◽  
Fabio Bernasconi ◽  
Fabio Magatti ◽  
Bruno Frea ◽  
...  

Cancers ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 429
Author(s):  
Julian Hipp ◽  
Blin Nagavci ◽  
Claudia Schmoor ◽  
Joerg Meerpohl ◽  
Jens Hoeppner ◽  
...  

Background: A substantial fraction of patients with esophageal cancer show post-neoadjuvant pathological complete response (pCR). Principal esophagectomy after neoadjuvant treatment is the standard of care for all patients, although surveillance and surgery as needed in case of local recurrence may be a treatment alternative for patients with complete response (CR). Methods: We performed a scoping review to describe key characteristics of relevant clinical studies including adults with non-metastatic esophageal cancer receiving multimodal treatment. Until September 2020, relevant studies were identified through systematic searches in the bibliographic databases Medline, Web of Science, Cochrane Library, Science Direct, ClinicalTrials, the German study register, and the WHO registry platform. Results: In total, three completed randomized controlled trials (RCTs, with 468 participants), three planned/ongoing RCTs (with a planned sample size of 752 participants), one non-randomized controlled study (NRS, with 53 participants), ten retrospective cohort studies (with 2228 participants), and one survey on patients’ preferences (with 100 participants) were identified. All studies applied neoadjuvant chemoradiation protocols. None of the studies examined neoadjuvant chemotherapeutic protocols. Studies investigated patient populations with esophageal squamous cell carcinoma, adenocarcinoma, and mixed cohorts. Important outcomes reported were overall, disease-free and local recurrence-free survival. Limitations of the currently available study pool include heterogeneous chemoradiation protocols, a lack of modern neoadjuvant treatment protocols in RCTs, short follow-up times, the use of heterogeneous diagnostic methods, and different definitions of clinical CR. Conclusion: Although post-neoadjuvant surveillance and surgery as needed compared with post-neoadjuvant surgery on principle has been investigated within different study designs, the currently available results are based on a wide variation of diagnostic tools to identify patients with pCR, short follow-up times, small sample sizes, and variations in therapeutic procedures. A thoroughly planned RCT considering the limitations in the currently available literature will be of great importance to provide patients with CR with the best and less harmful treatment.


1988 ◽  
Vol 97 (4) ◽  
pp. 376-380 ◽  
Author(s):  
Bruce N. Benjamin ◽  
Henley Harrison ◽  
Paul A. Gatenby ◽  
Kaye Cameron ◽  
Robert Kitchen ◽  
...  

Ten patients received lymphoblastoid alpha-interferon (Wellferon) in a crossover study so that Wellferon and standard microsurgical laryngeal laser therapy could be compared to laser therapy alone. Wellferon was administered initially at an intravenous high dose of 15 megaunits/m2 for 5 days followed by a daily dose of 2 megaunits/m2 subcutaneously for 6 months. Dosage was adjusted according to predefined toxicity. One patient was withdrawn from the study. Of the others, all but one received over 75 % of the planned total dose. At follow-up of the nine assessable patients, complete remission was achieved in two of them, partial remission in four, and no response in the remainder. The two complete remissions were sustained for 2 years, but the four partial remissions were not sustained. Thus, a role for alpha-interferon in the kind of regimen used here remains to be established.


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