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Session Item

Monday
August 30
10:30 - 11:30
Room 1
Proffered papers 31: Head and neck
Hans Langendijk, The Netherlands;
Pierre Blanchard, France
Proffered papers
Clinical
10:30 - 10:40
Long-term follow up of a RCT of Accelerated Radiotherapy for early Glottic Cancer (JCOG 0701A3)
Takeshi Kodaira, Japan
OC-0514

Abstract

Long-term follow up of a RCT of Accelerated Radiotherapy for early Glottic Cancer (JCOG 0701A3)
Authors:

Takeshi Kodaira1, Yoshikazu Kagami2, Ryunosuke Machida3, Naoto Shikama4, Yoshinori Ito2, Satoshi Ishikura5, Yoshihiro Saito6, Yasuo Matsumoto7, Koji Konishi8, Naoya Murakami9, Tetsuo Akimoto10, Yuuki Fukushima11, Takashi Toshiyasu12, Keiichi Nakagawa13, Yasushi Nagata14, Hirofumi Ogawa15, Takashi Uno16, Yasushi Hamamoto17, Yasumasa Nishimura18

1Aichi Cancer Center, Department of Radiation Oncology, Nagoya, Japan; 2Showa University School of Medicine, Department of Radiation Oncology, Tokyo, Japan; 3National Cancer Center, Japan Clinical Oncology Group Data Center, Tokyo, Japan; 4Jyuntendo University, Department of Radiation Oncology, Tokyo, Japan; 5Nagoya City University Graduate School of Medical Sciences, Department of Radiology, Nagoya, Japan; 6Saitama Cancer Center Hospital, Department of Radiation Oncology, Saitama, Japan; 7Niigata Cancer Center Hospital, Department of Radiation Oncology, Niigata, Japan; 8Osaka International Cancer Institute, Department of Radiation Oncology, Osaka, Japan; 9National Cancer Center Hospital , Department of Radiation Oncology, Tokyo, Japan; 10National Cancer Center Hospital East, Department of Radiation Oncology, Kashiwa, Japan; 11Sapporo Medical University, Department of Radiology, Sapporo, Japan; 12The Cancer Institute Hospital of JFCR, Department of Radiation Oncology, Tokyo, Japan; 13Tokyo University, Department of Radiology, Tokyo, Japan; 14Hiroshima University, Department of Radiation Oncology, Hiroshima , Japan; 15Shizuoka Cancer Center, Division of Radiation Oncology, Shizuoka, Japan; 16Chiba University Hospital, Department of Radiology, Chiba , Japan; 17Shikoku Cancer Center, Department of Radiation Oncology, Matsuyama, Japan; 18Kindai University Faculty of Medicine, Department of Radiation Oncology, Osaka-Sayama, Japan

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Purpose or Objective

JCOG0701A3 is designed to assess results with long-term follow up of JCOG0701, as of a randomized controlled trial comparing efficacy of accelerated fractionation with 2.4 Gy/fraction (Ax group) to that of standard fractionation with 2 Gy/fraction (SF group) for glottic cancer (GC).

Material and Methods

GC of T1-2N0M0, were treated with 66/70 Gy for T1/T2 in SF group, while 60/64.8 Gy in Ax group in JCOG0701. The primary analysis underwent on February, 2016, and reported in 2018. Present analysis was designed to add additional results with longer follow up progression-free survival (PFS), overall survival (OS), larynx progression-free survival (LPFS), and late adverse events adding central nervous system ischemia (CNSI). The analysis was conducted in June 2020.

Results

There were 370 patients randomized to SF and Ax group with 184 and 186 patients, respectively. Patients were adjusted for T category and institute at randomization. All patients included 356 males/14 females, and 341/29 patients with PS 0/1. Median age was 68 (range, 35−80). Among SF group, 138/46 patients had T1/T2 disease, while 140/42 had T1/T2 in Ax group. 

In this ancillary analysis, the median follow-up period of the entire /those without disease progression was 7.1/8.0 years (range, 0.1−12.4/0.1-12.4). At last follow-up, 45/260 patients were alive with/without disease progression and 65 patients died. As of SF/Ax group, 8/9 patients died of the primary disease, 23/17 of other cause, 1/1 of treatment related death and 1/5 of unknown reasons, respectively. The 7-years cumulative incidences of local failure at last follow up of SF/Ax group were 18.4%/10.9%, and those of regional or distant failure and those of death were 2.2%/6.7%, and 6.1%/7.5%, respectively.

The 5 and 7-years PFS of SF/Ax group was 76.2%/78.2% and 72.7%/74.8%, and the 5 and 7-years OS of SF/Ax group was 92.7%/89.6% and 90.8%/86.5%, LPFS of both group was 77.8%/80.9 and 74.4%/77.6%, respectively. 

As for late toxicity (≥91 days), 14.3%/7.6% of ≥grade 2 and 3%/1.6% of ≥grade 3 observed in SF/Ax group. Incidence of ≥grade 2 of laryngeal edema and voice change were 1.7%/0.5% and 9.3%/5.4% in SF/Ax groups, respectively. The late adverse event at 8 years of SF/Ax group was 11.9%/7.4%, respectively. Late adverse event of Ax group showed favorable tendency compared to Sx group (HR 0.529, 95% CI 0.278-1.007, p=0.055). As for CNSI of ≥grade 2, 4.1%/1.1%/2.7% was observed in SF/Ax/entire group. 

Conclusion

In this long follow-up analysis, Ax group remained slightly favorable efficacy with tendency for lower incidence of late adverse event including CNSI compared to SF group. With relatively long follow-up data, Ax was comparable to SF in efficacy and safety. Accelerated fractionated regimen may be suitable for early GC because of its convenience in sparing treatment time, cost, and labor.