Combination of neoadjuvant and adjuvant chemotherapy with FOLFOX compared with adjuvant chemotherapy in management of locally advanced rectal cancers: a randomized trial of a promising therapeutic approach.

BACKGROUND: Colorectal cancer (CRC) is a significant malignancy with widespread implications. Despite progress in surgical interventions for rectal cancer, improvements in overall prognosis remain disproportionate. Standard preoperative chemoradiation, while established as the standard treatment for the majority of rectal cancers, exhibits limited effectiveness in enhancing disease-free survival (DFS) and mitigating distant metastases, particularly in cases of locally advanced rectal cancer (LARC). METHODS: This randomised clinical trial assessed 286 patients with LARC in two paralleled groups. Group A underwent six courses of neoadjuvant MFOLFOX chemotherapy, chemoradiation, surgery, and six adjuvant chemotherapy cycles. Group B received concurrent chemoradiation, surgery, and twelve adjuvant chemotherapy cycles. Patient evaluations were achieved at multiple stages of treatment and follow-up. RESULTS: Group A had significantly lower local recurrence (11.64%) than Group B (21.74%, P = 0.025). The distant metastasis rate in Group A (8.90%) was lower than in Group B (20.29%) but was not significant (p = 0.143). More patients in Group A experienced downstaging (80.82% vs. 60.87%, p < 0.001). Specifically, 72.60% demonstrated downstaging of tumour invasion and 54.79% downstaging of lymph node involvement, compared to 57.25% and 41.30% in Group B (p = 0.009 and p = 0.025, respectively) as well as higher pCR rate (26.03% vs. 15.25%, p = 0.030) and three-year DFS rate (82.19% vs. 71.01%, p = 0.035) in group A compare to group B. CONCLUSION: This innovative strategy for LARC showed promising results with lower local recurrence and higher rates of downstaging and pCR. Treatment side effects were similar in both groups but less frequent in Group A. Anaemia was the most common haematological side effect (A: 58%, B: 68%), and peripheral sensory neuropathy was the most common non-haematological complication (A: 63%, B: 64%). These findings suggest this regimen could be a valuable therapeutic approach for LARC. TRIAL REGISTRATION: This trial was registered on 2023-12-08 within the IRCT.IR database under the number IRCT20210308050628N1.

Validation of an individualized home-made superficial brachytherapy mold applied for deep nonmelanoma skin cancer.

Background: This study was conducted to evaluate the effect of brachytherapy (BT) customized mold [Condensation silicone elastomer (ProtesilTM)] and its thickness on the dose distribution pattern of deep nonmelanoma skin cancers (NMSC). Materials and methods: Four blocks of mold material were constructed in 5, 10, 15, and 20 mm thickness and 100 × 100 mm2 area by a plastic cast. The high dose rate (HDR) plus treatment planning system (TPS) (Version 3, Eckert & Ziegler BEBIG Gmbh, Berlin, Germany) with a 60Co source (model: Co0.A86, EZAG BEBIG, Berlin, Germany) as an high dose rate brachytherapy (HDR-BT) source was used. Solid phantom and MOSFETTM and GAFCHROMICTM EBT3 film dosimeters were used for experimental dosimetry of the different thicknesses (up to 20 mm) of BT customized mold. Skin dose and dose to different depths were evaluated. Result: The TPS overestimated the calculated dose to the surface. Skin dose can be reduced from 250% to 150% of the prescription dose by increasing mold thickness from 5 mm to 20 mm. There was a 7.7% difference in the calculated dose by TPS and the measured dose by MOSFET. There was a good agreement between film dosimetry, MOSFET detector, and TPS' results in depths less than 5 mm. Conclusion: Each BT department should validate any individualized material chosen to construct the customized surface BT mold. Increasing the mold thickness can treat lesions without overexposing the skin surface. Superficial BT can be recommended as an appropriate treatment option for some deep NMSC lesions (up to 20 mm) with pre-planning considerations employing thicker molds.