Long-term outcomes of neoadjuvant-synchronous S-1 plus radiotherapy for locally advanced rectal cancer: a multi-institutional prospective phase II study

Etoh, Tsuyoshi; Hara, Takao; Akagi, Tomonori; Tahara, Koichiro; Matsumoto, Toshifumi; Ogawa, Tadashi; Fujii, Kyuzo; Shiromizu, Akio; Shiroshita, Hidefumi; Ito, Masafumi

doi:10.23922/jarc.2018-011

Cited by 5 publications

(10 citation statements)

References 24 publications

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“…S-1, a prodrug of 5-FU, is one of the candidates for this chemotherapy regimen in Japan. There are several reports on S-1 alone [ 20–25 ] and combined therapy with other chemotherapeutic agents [ 15–19 ] for preoperative CRT for LARC, but there are few reports showing the treatment outcomes of S-1 alone, especially with regard to long-term results [ 25 ]. Table 6 shows the results of CRT using S-1 alone.…”

Section: Discussionmentioning

confidence: 99%

“…S-1 alone could be a useful option for preoperative CRT for LARC. However, there are very few reports on the treatment outcomes of preoperative CRT with S-1 alone for LARC, especially regarding long-term results [ 25 ], and the number of patients in these studies was limited [ 20–25 ]. In this study, we retrospectively assessed the efficacy and tolerability of S-1 in preoperative CRT for LARC.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and tolerability of preoperative chemoradiotherapy with S-1 alone for locally advanced rectal cancer

Imano

Murakami

Kubo

et al. 2020

Journal of Radiation Research

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Preoperative chemoradiotherapy with capecitabine or 5-fluorouracil is a standard treatment for locally advanced rectal cancer (LARC). S-1, a prodrug of 5-fluorouracil, is a candidate for this chemoradiotherapy regimen in Japan; however, treatment outcomes after S-1 treatment alone are not clear. This study aimed to assess the efficacy and tolerability of preoperative chemoradiotherapy with S-1 alone for LARC. We retrospectively evaluated 54 LARC patients who underwent preoperative chemoradiotherapy with S-1 alone in our institution between 2005 and 2017. The clinical tumor stage was cT2–3 in 31 patients and cT4 in 23 patients, and lymph node metastases were clinically evident in 31 patients. S-1, at a dose of 80 mg/m2/day, was orally administered during radiotherapy. A total dose of 45–50.4 Gy was delivered in 25–28 fractions (median: 50.4 Gy). Surgical resections were scheduled 6–10 weeks after chemoradiotherapy completion. The 3- and 5-year overall survival rates were 92.4 and 72.8%, respectively, with a median follow-up time of 51 months. The 3- and 5-year local control rates were 96.2 and 85.9%, respectively. A pathological complete response was observed in 7 patients (13.0%) at the time of surgery. Ten patients (18.5%) had grade 3 acute toxicities and 5 patients (9.3%) had grade 3 late toxicities. No grade 4 or 5 toxicities were observed. Preoperative chemoradiotherapy with S-1 alone followed by total mesorectal excision resulted in a low incidence of toxicities and comparable clinical results. Therefore, S-1 alone can be a treatment option for preoperative chemoradiotherapy in LARC patients.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Efficacy and tolerability of preoperative chemoradiotherapy with S-1 alone for locally advanced rectal cancer

Imano

Murakami

Kubo

et al. 2020

Journal of Radiation Research

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“…In a report by Hiratsuka et al [35] on long-term prognosis, the rates of local recurrence, lung metastasis, and liver metastasis were 13.5%, 16.2%, and 2.7%, respectively. In the present study, although the observation period was only 3 years, the recurrence after surgery was well controlled, with only three patients (11%) experiencing lung metastasis.…”

Section: Discussionmentioning

confidence: 95%

Efficacy and Safety of Preoperative Chemoradiotherapy With S-1 for Advanced Rectal Cancer: A Phase II Study

Ushigome

Funahashi

Kaneko

et al. 2021

Preprint

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Background: Preoperative chemoradiotherapy (CRT) for patients with rectal cancer has not yet been established in Japan. We conducted a non-randomized phase II study to evaluate the efficacy and safety of preoperative CRT with S-1, a fixed-dose combination of tegafur, gimeracil, and oteracil potassium. Methods: We conducted a prospective, interventional, single-center study. Radiotherapy was administered at a total dose of 45 Gy (1.8 Gy in 25 fractions) for five weeks. S-1 was administered orally for a total of nine weeks (five weeks during and four weeks after radiotherapy) at a dose of 80 mg/m2/day. The endpoint was the pathological complete response (pCR) rate. The required sample size was calculated to be 30 individuals. The characteristics of the 28 patients included were as follows: cStage (II:12/ III:16), median age of 66 years (range 40–77 years), male/female (20/8), and lesion site (Ra-Rb:3/Rb:23/Rb-P:2). Results: Preoperative treatment was completed in 27 patients (96%). Treatment abandon was because of diarrhea. Grade 3 or higher adverse events were observed in only two patients (7%). Clinical downstaging was performed in eight patients (29%). Radical resection was achieved in 27 patients (96%), including 19 (68%) who underwent sphincter-preserving surgery. The pCR rate was 11% (three patients). The three-year disease-free survival rate was 79%, and the overall survival was 89%. No local recurrence occurred three years after surgery. Conclusions: Preoperative CRT with S-1 has an acceptable safety profile, and can potentially contribute to preserving anal function in patients with rectal cancer.Trial registration: UMIN Clinical Trial Registry: UMIN000013598. Registered 1 April 2014, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015887

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“…In addition, we only examined the short-term results. Only one study from Hiratsuka et al (12) reported the long-term outcomes of CRT with S-1 for locally advanced rectal cancer, noting a 5-year disease-free survival and 5-year overall survival of 66.7 and 74.7%, respectively, for Stage II and III rectal cancer. Therefore, further studies will be needed to confirm the efficacy of preoperative CRT with S-1 for locally advanced rectal cancer, including an assessment of the long-term outcomes regarding disease free survival and local recurrence, and sexual and urinary function.…”

Section: Discussionmentioning

confidence: 99%

“…S-1 contains not only tegafur as a radiosensitizer but also gimeracil, which enhances the efficacy of the radiotherapy (7)(8)(9). However, few studies regarding preoperative CRT with S-1 for rectal cancer have been conducted thus far (10)(11)(12).…”

Section: Introductionmentioning

confidence: 99%

Short‑term outcomes of preoperative chemoradiotherapy with S‑1 for locally advanced rectal cancer

et al. 2020

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The purpose of the present study was to evaluate the short-term results of preoperative chemoradiation therapy with S-1 for locally advanced rectal cancer. A total of 32 patients with advanced rectal cancer who had been treated with preoperative chemoradiotherapy with S-1 and underwent surgical resection between May 2012 and December 2019 were analyzed. Advanced rectal cancer of clinical stage II and III was diagnosed in 13 (41%) and 19 (59%) patients, respectively. Therapeutic toxicities of anemia (24 patients; 75%), anal pain (22 patients; 69%) and skin and subcutaneous tissue disorders (19 patients; 59%) were frequently observed in all grades. Grade ≥3 leukopenia, anemia, neutrophil count reduction, platelet count reduction and diarrhea were identified in 2 (6%), 1 (3%), 1 (3%), 1 (3%) and 1 (3%) patients, respectively. A total of 29 patients (91%) completed this therapy without any change to the protocol or dosage. R0 resection was performed in 100% of the patients, and no postoperative mortality was observed. Pathological complete response was observed in 9 cases (28.1%). This therapy can be considered for cases of locally advanced rectal cancer due to its acceptable toxicity and relatively high antitumor effect.

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Long-term outcomes of neoadjuvant-synchronous S-1 plus radiotherapy for locally advanced rectal cancer: a multi-institutional prospective phase II study

Cited by 5 publications

References 24 publications

Efficacy and tolerability of preoperative chemoradiotherapy with S-1 alone for locally advanced rectal cancer

Efficacy and tolerability of preoperative chemoradiotherapy with S-1 alone for locally advanced rectal cancer

Efficacy and Safety of Preoperative Chemoradiotherapy With S-1 for Advanced Rectal Cancer: A Phase II Study

Short‑term outcomes of preoperative chemoradiotherapy with S‑1 for locally advanced rectal cancer

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