A phase I/II radiation dose escalation trial using simultaneous integrated boost technique with elective nodal irradiation and concurrent chemotherapy for unresectable esophageal Cancer

Li, Chen; Ni, Wenjie; Wang, Xin; Zhou, Zongmei; Deng, Wei; Chang, Xiao; Chen, Dongfu; Feng, Qinfu; Liang, Jun; Wang, Xiaozhen; Deng, Lei; Wang, Wenqing; Bi, Nan; Zhang, Tao; Xiao, Zefen

doi:10.1186/s13014-019-1249-5

Cited by 24 publications

(29 citation statements)

References 22 publications

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“…Besides different definitions of LCR, one reason for this difference could be the use of higher SIB doses of 63 Gy. The significance of patient selection is well-reflected in a recent study of Li et al including patients only up to an age of 70 years with Karnofsky indices of at least 70%, resulting in 1-year OS and LCR rates of 76.9% and 78.8% [ 28 ]. Patients in our cohort were older than most cohorts previously published with a median age of 72 years, reflecting the actual clinical challenge in many western countries facing demographic changes towards growing proportions of elderly people.…”

Section: Discussionmentioning

confidence: 99%

Simultaneous integrated boost concepts in definitive radiation therapy for esophageal cancer: outcomes and toxicity

et al. 2021

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Background Radiation therapy and chemoradiation therapy play a major role in the definitive management of esophageal cancer. Survival in esophageal cancer patients is still relatively poor, mostly due to high rates of local recurrence and distant metastases. It is hypothesized that dose escalation in radiotherapy could improve outcomes. Therefore, this retrospective analysis aimed to investigate the outcomes and toxicity in patients treated with local dose escalation by means of using simultaneous integrated boost concepts. Methods Between 2012 and 2018, 101 patients with esophageal carcinoma were analyzed in this monocentric, retrospective study. All patients received definitive chemoradiation or radiation therapy alone as intensity modulated radiotherapy. The prescribed dose was 50.4 Gy in 28 fractions to the primary tumor and the elective lymph nodes as well as a simultaneous integrated boost (SIB) with 58.8 Gy to macroscopic tumor and lymph node metastases. Endpoints were overall survival (OS), progression free survival (PFS), local control rate (LCR) and toxicity. Results 60 patients (59.4%) received chemoradiation, 41 patients (40.6%) radiotherapy alone. The median follow up was 17 months (range 0–75 months). OS, PFS and LCR were at 63.9%, 53.9% and 59.9% after 1 year and 37.6%, 34.5% and 36.1%, respectively after 3 years. 16 patients (15.8%) in total developed a locoregional recurrence within the field of radiation. In 48 patients (47.5%) at least one grade III° (CTCAE) toxicity was documented during radiotherapy, mostly dysphagia (36 pat., 75%). One patient suffered from a grade IV° pneumonia. Conclusion This retrospective analysis demonstrates that a SIB concept in definitive (chemo)radiation therapy is safe and feasible, showing acceptable outcomes in this patient cohort. Considering that this cohort mainly consists of elderly patients not eligible for chemotherapy in many cases, we emphasize the aspect of SIB radiation therapy as potential partial compensation for omitted simultaneous chemotherapy. Prospective studies are needed for validation.

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Section: Discussionmentioning

confidence: 99%

Simultaneous integrated boost concepts in definitive radiation therapy for esophageal cancer: outcomes and toxicity

et al. 2021

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“…In contrast, Song et al demonstrated that 60 Gy dCRT with paclitaxel plus cisplatin treatment for selected elderly patients resulted in encouraging survival outcomes (MST, 26.8 months; 2-years OS for stage I–II and III–IV patients, 76.0 and 38.6%, respectively) and tolerable toxicities (highest grade 3/4, leukopenia, 30.5%). In our institutional experience, only 70% of ESCC patients aged ≤ 70 years could complete at least 5 weekly doublet chemotherapy sessions (paclitaxel plus nedaplatin) during dCRT ( 6 ).…”

Section: Discussionmentioning

confidence: 99%

“…We designed this study due to the following reasons: First, we previously conducted a prospective phase I/II trial investigating the safety and feasibility of simultaneous integrated boost radiotherapy (SIB-RT) with concurrent chemotherapy in patients with unresectable ESCC, and determined that the recommended SIB-RT dose was 59.92 Gy/50.40 Gy in 28 fractions ( 6 ). Second, the fourth-generation oral fluoropyrimidine S-1 yielded a higher tumor response than and was non-inferior to infusional 5-fluorouracil and UFT (a combination of tegafur and uracil) in phase III trials of patients with gastrointestinal cancer ( 7 , 8 ).…”

Section: Introductionmentioning

confidence: 99%

S-1–Based Chemoradiotherapy Followed by Consolidation Chemotherapy With S-1 in Elderly Patients With Esophageal Squamous Cell Carcinoma: A Multicenter Phase II Trial

Wang

et al. 2020

Front. Oncol.

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Introduction: Intensive treatments can often not be administered to elderly patients with esophageal squamous cell carcinoma (ESCC), leading to a poorer prognosis. This multi-center phase II trial aimed to determine the toxicity profile and efficiency of S-1–based simultaneous integrated boost radiotherapy (SIB-RT) followed by consolidation chemotherapy with S-1 in elderly ESCC patients and to evaluate the usefulness of comprehensive geriatric assessment (CGA). Patients and Methods: We prospectively enrolled 46 elderly patients (age ≥ 70 years) with histopathologically proven ESCC. The patients underwent pretreatment CGA followed by SIB-RT (dose, 59.92 Gy/50.4 Gy) in 28 daily fractions administered using intensity-modulated radiotherapy or volumetric-modulated arc therapy. S-1 was orally administered (40–60 mg/m 2 ) concurrently with radiotherapy and 4–8 weeks later, for up to four 3-week cycles at the same dose. Results: The median survival time was 22.6 months. The 1- and 2-year overall survival rates were 80.4 and 47.8%, respectively. The overall response rate was 78.3% (36/46). The incidence of grade 3–4 toxicities was 28% (13/46). The most common grade 3–4 toxicities were radiation esophagitis (5/46, 10.9%), nausea (4/46, 8.7%), anorexia (3/46, 6.5%), and radiation pneumonitis (3/46, 6.5%). There were no grade 5 toxicities. CGA identified that 48.8% of patients were at risk for depression and 65.5% had malnutrition. Conclusion: Concurrent S-1 treatment with SIB-RT followed by 4 cycles of S-1 monotherapy yielded satisfactory tumor response rates and manageable toxicities in selected elderly patients with ESCC. Pretreatment CGA uncovered numerous health problems and allowed the provision of appropriate supportive care. Clinical Trial Registration: www.ClinicalTrials.gov , identifier: NCT02979691.

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“…This may be because the distant metastasis rate was low (28.4%), and most distant metastases (72.0%) were combined with local‐regional recurrences. Another radiation dose escalation method, simultaneous integrated boost (SIB), has also been explored; local control of 67.5%‐78.6% was reported . However, local control of ESCC was not improved by SIB, compared with standard dose .…”

Section: Discussionmentioning

confidence: 99%

Sequential boost of intensity‐modulated radiotherapy with chemotherapy for inoperable esophageal squamous cell carcinoma: A prospective phase II study

et al. 2020

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Purpose: This prospective phase II study aimed to determine the efficacy and tolerability of sequential boost of intensity-modulated radiation therapy (IMRT) with chemotherapy for patients with inoperable esophageal squamous cell carcinoma (ESCC). Methods: Patients with histologically or cytologically proven inoperable ESCC were enrolled in this study (ChiCTR-OIC-17010485). A larger target volume for subclinical lesion was irradiated with 50 Gy, and then, a smaller target volume only including gross tumor was boosted to 66 Gy. The fraction dose was 2 Gy, and no elective node was irradiated. Concurrent and consolidation chemotherapy of fluorouracil (600 mg/m 2 , days 1-3) plus cisplatin (25 mg/m 2 , days 1-3) was administered every 4 weeks, for 4 cycles in total. The primary endpoint was 2-year progressionfree survival (PFS). Results: Eighty-eight patients were enrolled in this study. The median age was 65 years (range: 45-75 years), and 69 patients (78.4%) were men. With the median follow-up of 26 (range: 3-95) months, the 2-and 5-year PFS were 39.3% and 36.9%, respectively, and overall survival (OS) were 57.1% and 39.2%, respectively. Tumor stage and concurrent chemotherapy were independent OS predictors. Major acute adverse events were myelosuppression and esophagitis, most of which were grades 1-2.Nine percent and 2.3% of patients had grade 3 acute esophagitis and late esophageal strictures, respectively. Conclusions: Sequential boost to 66 Gy by IMRT with chemotherapy was safe and effective for inoperable ESCC. A randomized phase III study to compare with standard dose of 50 Gy is warranted. K E Y W O R D Schemoradiotherapy, esophageal squamous cell carcinoma, intensity-modulated radiotherapy

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A phase I/II radiation dose escalation trial using simultaneous integrated boost technique with elective nodal irradiation and concurrent chemotherapy for unresectable esophageal Cancer

Cited by 24 publications

References 22 publications

Simultaneous integrated boost concepts in definitive radiation therapy for esophageal cancer: outcomes and toxicity

Simultaneous integrated boost concepts in definitive radiation therapy for esophageal cancer: outcomes and toxicity

S-1–Based Chemoradiotherapy Followed by Consolidation Chemotherapy With S-1 in Elderly Patients With Esophageal Squamous Cell Carcinoma: A Multicenter Phase II Trial

Sequential boost of intensity‐modulated radiotherapy with chemotherapy for inoperable esophageal squamous cell carcinoma: A prospective phase II study

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