Background and Objectives: The standard treatment for locally advanced rectal cancer (LARC) includes neoadjuvant chemoradiotherapy (nCRT), followed by surgery with or without adjuvant chemotherapy (CT). This study evaluated the efficacy and safety of dose-escalated radiotherapy (RT) using the volumetric modulated arc therapy–simultaneous integrated boost (VMAT–SIB) technique in patients with LARC compared to 3D conformal radiotherapy (3D-CRT). Materials and Methods: This study prospectively enrolled 75 patients with LARC. All patients received nCRT using VMAT–SIB, delivering a tumor dose (TD) of 54 Gy in 25 fractions, with concomitant CT following the 5-fluorouracil and leucovorin (5-FU–LV) protocol. To compare the treatment outcomes and toxicity associated with the increased RT dose, a retrospective cohort of 62 patients treated with the 3D-CRT technique was analyzed. The 3D-CRT group received a TD of 50.4 Gy in 28 fractions with the same CT. Outcomes, including pathological complete response (pCR), tumor regression grade (TRG), and sphincter preservation rates, were compared. Results: Among operated patients, the group treated with VMAT–SIB demonstrated improved rates of pCR (20.6% vs. 8.9%), with a statistically significant trend (p = 0.06). Sphincter-preserving surgeries were performed in 49 out of 63 operated patients (77.8%) in the VMAT–SIB group, compared to 35 out of 56 (62.5%) in the 3D-CRT group. Analysis of the definitive postoperative stage revealed a significantly higher prevalence of lower T categories (T0–2) (p < 0.01), negative N status (p < 0.05), and lower stages (I + II) (p < 0.05) in patients treated with the intensified RT approach. However, no significant differences in acute toxicity were observed. Conclusions: The implementation of intensified treatment with a higher dose using the VMAT–SIB technique demonstrated significant benefits in downsizing and downstaging compared to the standard treatment approach. These findings support its integration into clinical practice. However, further prospective, multi-center studies are needed to validate these results and assess long-term outcomes.

Background and Objectives: The standard treatment for locally advanced rectal cancer (LARC) includes neoadjuvant chemoradiotherapy (nCRT), followed by surgery with or without adjuvant chemotherapy (CT). This study evaluated the efficacy and safety of dose-escalated radiotherapy (RT) using the volumetric modulated arc therapy-simultaneous integrated boost (VMAT-SIB) technique in patients with LARC compared to 3D conformal radiotherapy (3D-CRT). Materials and Methods: This study prospectively enrolled 75 patients with LARC. All patients received nCRT using the VMAT-SIB, delivering a tumor dose (TD) of 54 Gy in 25 fractions, with concomitant CT following the 5-fluorouracil and leucovorin (5-FU-LV) protocol. To compare the treatment outcomes and toxicity associated with the increased RT dose, a retrospective cohort of 62 patients treated with 3D-CRT techique was analyzed. The 3D-CRT group received a TD of 50.4 Gy in 28 fractions with the same CT. Outcomes, including pathological complete response (pCR), tumor regression grade (TRG), and sphincter preservation rates, were compared. Results: Among operated patients, the group treated with the VMAT-SIB demonstrated improved rates of pCR (20.6% vs. 8.9%), with a statistically significant trend (p = 0.06). Sphincter-preserving surgeries were performed in 49 out of 63 operated patients (77.8%) in VMAT-SIB group, compared to 35 out of 56 (62.5%) in 3D-CRT group. Analysis of definitive postoperative stage revealed a significantly higher prevalence of lower T categories (T0-2) (p < 0.01), negative N status (p < 0.05), and lower stages (I+II) (p < 0.05) in patients treated with intensified RT approach. However, no significant differences in acute toxicity were observed. Conclusions: The implementation of intensified treatment with a higher dose using the VMAT-SIB technique demonstrated significant benefits in downsizing and downstaging compared to the standard treatment approach. These findings support its integration into clinical practice. However, further prospective, multi-center studies are needed to validate these results and assess long-term outcomes.

Purpose: To evaluate the clinical efficacy and safety of eye drops containing lyophilized amniotic membrane (AM) in the treatment of dry eye disease (DED), with a focus on tear film stabilization and epithelial–immune balance. Methods: In this prospective cohort study, 40 patients (80 eyes) with DED were followed over six visits. The primary outcome was tear break-up time (TBUT). Secondary outcomes included corneal and conjunctival staining graded by the Oxford scale, meibomian gland parameters, corneal sensitivity (Cochet–Bonnet esthesiometry), best-corrected visual acuity, intraocular pressure (IOP), and Schirmer I test. Continuous variables were analyzed using repeated-measures ANOVA with Greenhouse–Geisser correction and Bonferroni post hoc testing; ordinal outcomes were analyzed using the Friedman test with Dunn–Bonferroni correction. Results: TBUT increased significantly in both eyes (OD: +5.3 s; OS: +4.9 s; both p < 0.001; ηp² ≈ 0.33). Corneal and conjunctival staining scores decreased (p < 0.001), meibomian gland quality and expressibility improved (p < 0.001), and corneal sensitivity increased (p < 0.001), while visual acuity and IOP remained stable. Schirmer I values showed no significant change. The combined pattern of changes (TBUT ↑, staining ↓, meibum/expressibility ↑, sensitivity ↑) indicates tear film stabilization and ocular surface improvement with a preserved safety profile. Conclusions: Lyophilized AM eye drops significantly prolong TBUT and improve clinical signs of DED, presumably by restoring the extracellular matrix (ECM) niche and the heavy-chain hyaluronan/pentraxin 3 (HC-HA/PTX3) complex, reducing proteolytic burden, and promoting a pro-resolving immune balance, with potential neurotrophic effects. These findings support the adjunctive use of AM-derived eye drops within contemporary TFOS DEWS II-based management algorithms for dry eye disease.

Background/Objectives: Dry eye disease (DED) affects daily visual functioning and vision-related quality of life in addition to tear film stability and ocular surface integrity. In a previously published prospective cohort, lyophilized amniotic membrane (AM) eye drops were associated with significant improvements in objective ocular surface parameters. This secondary analysis evaluated whether treatment with lyophilized AM eye drops was accompanied by changes in patient-reported outcomes, specifically vision-related quality of life and dry eye symptoms. Methods: This secondary analysis included 40 consecutive patients with DED treated with lyophilized AM eye drops in repeated 14-day cycles over six study visits, while continuing their pre-existing standard DED therapy. Patient-reported outcomes were assessed at baseline and at the final visit using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and the Ocular Surface Disease Index-6 (OSDI-6). Item-level response distributions were compared between baseline and the final visit using non-parametric tests for paired ordinal data. A two-sided p value < 0.05 was considered statistically significant. Results: Global NEI VFQ-25 items, including general health, self-rated vision, and worry about eyesight, did not change significantly. In contrast, significant improvements were observed in ocular pain/discomfort (p = 0.002); near-vision activities, including reading ordinary print (p = 0.003), work or hobbies requiring near vision (p = 0.014); and finding objects on a crowded shelf or in a drawer (p = 0.008), as well as distance-related and spatial tasks, including reading street signs (p < 0.001) and noticing objects off to the side while walking (p = 0.037). Improvements were also observed in vision-related social functioning and dependence-related items. Five of six OSDI-6 items improved significantly: light sensitivity (p < 0.001), blurred vision (p = 0.008), difficulty with driving or night driving (p = 0.002), difficulty watching television (p = 0.008), and discomfort in windy conditions (p = 0.046). Discomfort in low-humidity environments showed a trend toward improvement but did not reach statistical significance (p = 0.059). Conclusions: In this secondary analysis of a prospective cohort, lyophilized AM eye drops were associated with significant improvements in several patient-reported domains of vision-related quality of life and dry eye symptoms. These findings complement previously reported objective improvements in tear film stability, ocular surface staining, meibomian gland function, and corneal sensitivity, suggesting that treatment with lyophilized AM eye drops was associated with improvements extending beyond ocular surface signs to patient-reported daily visual function and symptom burden in patients with DED.