Tolerability and Safety Assessment of Adjuvant Chemoradiotherapy with S-1 after Limited Surgery for T1 or T2 Lower Rectal Cancer
Abstract
:Simple Summary
Abstract
1. Introduction
2. Patients and Methods
2.1. Methods
2.2. Study Cohort and Eligibility
2.3. Surgical and Postoperative Treatment Protocol
2.4. Follow-Up and Evaluation
2.5. Sample Size Calculation
2.6. Statistical Analysis
3. Results
3.1. Patient Background
3.2. Primary and Secondary Endpoints
4. Discussion
5. Limitations
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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SM, N = 36 (%) | MP, N = 16 (%) | p Value | |
---|---|---|---|
Age, median (IQR) [<65/≥65] | 64 (54–68) 21 (58.3%)/15 (41.7%) | 70.5 (65–75) 4 (25.0%)/12 (75.0%) | 0.004 * 0.037 ** |
Sex [Male / Female] | 20 (55.6%)/16 (44.4%) | 7 (43.7%)/8 (56.3%) | 0.551 |
ECOG-PS [0/1] | 33 (100%)/0 (0%) | 14 (87.5%)/2 (12.5%) | 0.102 |
Location [Rb/P] | 35 (97.1%)/1 (2.9%) | 15 (93.7%)/1 (6.3%) | 1.000 |
Histological type [tub1/tub2] | 18 (51.4%)/17 (48.6%) | 6 (40.0%)/9 (60.0%) | 0.545 |
Greatest diameter (median/IQR) [<22/≥22] | 20 (18–25) 17 (50.0%)/17 (50.0%) | 23.5 (20–27) 6 (37.5%)/10 (62.5%) | 0.321 * 0.546 ** |
Lymphatic invasion [+/−] | 11 (30.6%)/25 (69.4%) | 8 (50.0%)/8 (50.0%) | 0.220 |
Venous invasion [+/−] | 13 (36.1%)/23 (63.9%) | 11 (68.8%)/5 (31.2%) | 0.038 |
Budding grade [1/2–3] | 23 (79.3%)/6 (20.7%) | 1 (25.0%)/3 (75.0%) | 0.052 |
Preoperative CEA, median (IQR) (ng/mL) [<2.0/≥2.0] | 1.95 (1.4–2.78) 18 (50.0%)/18 (50.0%) | 2.1 (1.55–3.23) 6 (37.5%)/10 (62.5%) | 0.579 0.549 ** |
Preoperative CA19-9, median (IQR) (ng/mL) [<6.5/≥6.5] | 6.5 (3.78–12.75) 18 (50.0%)/18 (50.0%) | 6.5 (3.4–9.75) 9 (56.3%)/7 (43.7%) | 0.960 * 1.000 ** |
Operation approach (Transanal excision/EMR or ESD) | 21 (58.3%)/15 (41.7%) | 16 (100%)/0 (0%) | 0.002 |
Operation time median (IQR) [<68/≥68] | 82 (45.3–99.5) 13 (43.3%)/17 (56.7%) | 59.5 (35.3–74.5) 10 (62.5%)/6 (37.5%) | 0.134 * 0.353 ** |
SM, N = 36 (%) | MP, N = 16 (%) | p Value | |
---|---|---|---|
Adverse events (Grade 3–4) [+/−] | 0 (0%)/36 (100%) | 1 (6.2%)/15 (93.8%) | 0.3077 |
Locoregional recurrence [+/−] | 2 (6.1%)/31 (93.9%) | 4 (26.7%)/11 (73.3%) | 0.0672 |
Regional lymph node recurrence | 0 (0%) | 1 (6.2%) | NA |
Case No. | Age | Sex | PS | Medical History | CEA (ng/mL) | CA19-9 (U/mL) | Surgery | Op time (min) | Blood Loss (mL) | Location | Tumor Size (mm) | Histology | Tumor Invasion | Ly | V | BD | Genetic Information |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 62 | F | 0 | None | 2.2 | 7 | TAE | 69 | 0 | Rb | 27 × 15 | tub2 | MP | 0 | 2 | NA | RAS-mt (KRAS G13D)/BRAF-wt/MSS |
2 | 70 | F | 0 | Varicose veins | 0.9 | <2 | TAE | 35 | 40 | Rb | 25 × 20 | tub2 | MP | 0 | 2 | NA | NA |
3 | 60 | F | 0 | Hypertension, appendicitis | 1.5 | 8 | TAE | 52 | 0 | Rb | 23 × 22 | tub2 | MP | 0 | 3 | 2 | RAS-mt |
4 | 49 | M | 0 | Anal fistula | 3.9 | 15 | TAE | 97 | 0 | Rb | 20 × 20 | tub2 | SM | 1 | 3 | 1 | RAS-wt/BRAF-wt/MSS |
5 | 73 | M | 0 | Asthma, AF | 2.4 | <2 | TAE | 67 | 0 | Rb | 13 × 13 | tub1 | MP | 0 | 1 | NA | MSS |
6 | 54 | F | 0 | None | 1.1 | 14 | ESD | 107 | 5 | Rb | 55 × 29 | tub2 | SM. | 1 | 0 | 1 | RAS-mt |
Factors | HR | 95% CI | p Value |
---|---|---|---|
Age [≥65/<65] | 0.697 | 0.156–3.116 | 0.637 |
Sex [Male/Female] | 0.706 | 0.317–6.330 | 0.649 |
Tumor invasion [MP/M.S.] | 6.178 | 1.197–31.890 | 0.030 |
Lymphatic invasion [+/−] | 4.722 | 0.568–39.240 | 0.151 |
Venous invasion [+/−] | 2.863 | 0.555–14.761 | 0.209 |
CEA [≥2.0/<2.0] | 1.152 | 0.258–5.149 | 0.853 |
CA19-9 [≥6.5/<6.5] | 1.39 | 0.311–6.217 | 0.666 |
Case No. | TS-1 Dosage (mg) | Dose Reduction or Discontinuation of Treatment | Complication (CD III or IV) | Recurrence Site | RFS (Month) | Survival Outcome | OS (Month) |
---|---|---|---|---|---|---|---|
1 | 80 | Discontinuation of TS-1 due to leukopenia (G2) * | None | Bilateral iliac lymph node | 57 | Survival | 69 |
2 | 120 | None | None | Local | 47 | Survival | 57 |
3 | 120 | None | None | Local, lung, pelvic lymph node | 9 | Death | 33 |
4 | 120 | None | None | Local | 34 | Death | 46 |
5 | 120 | None | None | Local | 22 | Death | 45 |
6 | 100 | None | None | Local | 13 | Death | 22 |
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Miyoshi, N.; Uemura, M.; Noura, S.; Yasui, M.; Nishimura, J.; Tei, M.; Matsuda, C.; Morita, S.; Inoue, A.; Tamagawa, H.; et al. Tolerability and Safety Assessment of Adjuvant Chemoradiotherapy with S-1 after Limited Surgery for T1 or T2 Lower Rectal Cancer. Cancers 2024, 16, 3360. https://doi.org/10.3390/cancers16193360
Miyoshi N, Uemura M, Noura S, Yasui M, Nishimura J, Tei M, Matsuda C, Morita S, Inoue A, Tamagawa H, et al. Tolerability and Safety Assessment of Adjuvant Chemoradiotherapy with S-1 after Limited Surgery for T1 or T2 Lower Rectal Cancer. Cancers. 2024; 16(19):3360. https://doi.org/10.3390/cancers16193360
Chicago/Turabian StyleMiyoshi, Norikatsu, Mamoru Uemura, Shingo Noura, Masayoshi Yasui, Junichi Nishimura, Mitsuyoshi Tei, Chu Matsuda, Shunji Morita, Akira Inoue, Hiroki Tamagawa, and et al. 2024. "Tolerability and Safety Assessment of Adjuvant Chemoradiotherapy with S-1 after Limited Surgery for T1 or T2 Lower Rectal Cancer" Cancers 16, no. 19: 3360. https://doi.org/10.3390/cancers16193360
APA StyleMiyoshi, N., Uemura, M., Noura, S., Yasui, M., Nishimura, J., Tei, M., Matsuda, C., Morita, S., Inoue, A., Tamagawa, H., Mokutani, Y., Yoshioka, S., Fujii, M., Kato, S., Sekido, Y., Ogino, T., Yamamoto, H., Murata, K., Doki, Y., & Eguchi, H., on behalf of Multicenter Clinical Study Group of Osaka University, Colorectal Group (CSGO-CG). (2024). Tolerability and Safety Assessment of Adjuvant Chemoradiotherapy with S-1 after Limited Surgery for T1 or T2 Lower Rectal Cancer. Cancers, 16(19), 3360. https://doi.org/10.3390/cancers16193360