A Phase I Trial of Bortezomib in Combination with Epirubicin, Carboplatin and Capecitabine (VECarboX) in Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma

PURPOSE:
The protease inhibitor bortezomib attenuates the action of NF-κB and has shown preclinical activity alone and in combination with chemotherapy.

DESIGN:
A Phase I dose-escalation study was performed administering bortezomib (0.7, 1.0, 1.3 and 1.6 mg m(-2) on days 1 and 8 from cycle 2 onwards) in combination with Epirubicin 50 mg m(-2) intravenously on day 1, Carboplatin AUC 5 day 1 and Capecitabine 625 mg m(-2) BD days 1-21 every 21 days (VECarboX regimen), in patients with advanced oesophagogastric adenocarcinoma. The primary objective was to define the maximum tolerated dose (MTD) of Bortezomib when combined with ECarboX.

RESULTS:
18 patients received bortezomib 0.7 (n = 6), 1.0 (n = 3), 1.3 (n = 6) and 1.6 mg m(-2) (n = 3) and a protocol amendment reducing the capecitabine dose to 500 mg m(-2) BD was enacted due to myelotoxicity. Common treatment-related non-haematological adverse events of any grade were fatigue (83.3 %), anorexia (55.6 %), constipation (55.6 %) and nausea (55.6 %). Common Grade 3/4 haematological toxicities were neutropenia (77.8 %) and thrombocytopenia (44.4 %). Objective responses were achieved in 6 patients (33.3 %) and a further 5 patients (27.8 %) had stable disease for >8 weeks.

CONCLUSIONS:
The addition of Bortezomib to ECarboX is well tolerated and response rates are comparable with standard chemotherapy.

Efficacy and safety of adjunctive mitomycin C during Ahmed Glaucoma Valve implantation:A prospective randomized clinical trial

Purpose To evaluate the efficacy and safety of intraoperative mitomycin C (MMC) in eyes undergoing Ahmed Glaucoma Valve implantation. Design Randomized controlled clinical trial. Participants Sixty patients with refractory glaucoma. Intervention Sixty eyes of 60 patients with refractory glaucoma were randomized to receive intraoperative MMC (0.5 mg/ml for 5 minutes) (n = 34) or balanced salt solution (n = 26) during Ahmed Glaucoma Valve implantation. Main outcome measures Surgical success was defined according to 2 different criteria: (1) postoperative intraocular pressure (IOP) between 6 and 21 mmHg, with or without antiglaucoma medications, and (2) IOP reduction of at least 30% relative to preoperative values. Eyes requiring additional glaucoma surgery, developing phthisis, or showing loss of light perception were classified as failures. Success rates in both groups were compared using Kaplan-Meier survival curves and the log rank test. Other outcome measures were mean IOP, number of glaucoma medications, and complications. Results After a mean follow-up of 12.3 months, Kaplan-Meier survival analysis showed a probability of success of 59% at 18 months for the MMC group and 61% for the control group when the first criterion for success was used (IOP between 6 and 21 mmHg). When an IOP reduction of at least 30% was used as the criterion to define success, the Kaplan-Meier survival analysis demonstrated a probability of success at 18 months of 62% for the MMC group and 67% for the control group. There were no significant differences in survival rates between the 2 groups with either criterion (P = 0.75 and P = 0.37, respectively). After 15 days postoperatively, the mean IOP did not significantly differ for both MMC and control eyes. Mean numbers of postoperative antiglaucoma medications were similar in MMC-treated eyes and controls. There was no significant difference between the incidences of postoperative complications in both groups. Conclusion Mitomycin C did not increase the short- or intermediate-term success rates of Ahmed Glaucoma Valve implantation. © 2004 by the American Academy of Ophthalmology.

Heparin induced thrombocytopenia causing life-threatening postoperative haemorrhage

Heparin is ubiquitously employed in surgery in the prevention and treatment of thromboembolic disorders. A small but significant number of patients receiving heparin develop thrombocytopenia and are at risk of both serious thromboembolic disease and haemorrhage. A case is reported where a young woman developed life-threatening postoperative haemorrhage associated with heparin induced thrombocytopenia (HIT).

The incidence and rate of rhegmatogenous retinal detachment seven years after cataract surgery in patients with high myopia

Background: Cataract extraction is the most commonly performed surgery in the National Health Service. Myopia increases the risk of postoperative rhegmatogenous retinal detachment (RRD). The aim of this study was to determine the incidence and rate of RRD seven years after cataract extraction in highly myopic eyes. Methods: Retrospective review was performed of notes of all high myopes (axial length 26.0 mm or more) who underwent cataract extraction during the study period in one centre. Results: 84 eyes met the study criteria. Follow-up time from surgery was 93 to 147 months (median 127 months). The average axial length was 28.72 mm (sd 1.37). Two eyes developed post-operative RRD; the incidence was 2.4% and the rate one RRD per 441.6 person-years. The results of 15 other studies on the incidence of RRD after cataract extraction in high myopia were pooled and combined with our estimate. Conclusion: Both patients in our study who developed RRD had risk factors for this complication as well as high myopia. Risk factors are discussed in the light of our results and the pooled estimate. Our follow-up time is longer than most. Future case series should calculate rates to allow meaningful comparison of case series. © The Ulster Medical Society, 2009.

Outcomes and projected impact on vision restoration of the China million cataract surgeries program

Purpose: The recently completed Chinese "Million Cataract Surgeries Program" (MCSP) is among the largest such campaigns ever, providing 1.05 million operations. We report MCSP outcomes for the first time, in Jiangxi, the province with the greatest program output. Methods: Ten county hospitals participating in MCSP were selected in Jiangxi (range of gross domestic product per capita US$743-2998). Each hospital sought to enroll 75 consecutive MCSP patients aged ≥50 years. Data recorded included type of cataract procedure, bilateral uncorrected visual acuity (UCVA) and best-corrected visual acuity (BCVA), and refractive error pre- and ≥50 days postoperatively. Results: Among 715 patients (mean age 72.3±9.1 years, 55.5% female), preoperative UCVA was <3/60 (legally blind) bilaterally in 13.3% and unilaterally in the operated eye in 50.9%. No subjects had UCVA >6/18 preoperatively. Small incision cataract surgery was performed in 92.3% patients. Among 662 patients (92.6%) completing follow-up was ≥ 40 days after surgery, BCVA was ≥6/18 in 80.1%, UCVA was ≥6/18 in 57.1% and UCVA was <3/60 in 2.1%. Older age (p<0.001), female sex (p=0.04), worse refractive error (p=0.02) and presence of intra- (p=0.002) and postoperative surgical complications (p<0.001), were independently associated with worse postoperative UCVA. Based on these results, the MCSP cured an estimated 124,950 cases (13.3%×[100-2.1%]×1.05 million) of bilateral and 502,500 (50.9%×[100-2.1%]×1.05 million) of unilateral blindness. Conclusions: Due to relatively good outcomes and the large number of surgeries performed on blind persons, the sight-restoring impact of the MCSP was probably substantial. © Informa Healthcare USA, Inc.

Determinants of pediatric cataract program outcomes and follow-up in a large series in Mexico.

PURPOSE:

To report determinants of outcomes and follow-up in a large Mexican pediatric cataract project.

SETTING:

Hospital Luis Sanchez Bulnes, Mexico City, Mexico.

METHODS:

Data were collected prospectively from a pediatric cataract surgery program at the Hospital Luis Sanchez Bulnes, implemented by Helen Keller International. Preoperative data included age, sex, baseline visual acuity, type of cataract, laterality, and presence of conditions such as amblyopia. Surgical data included vitrectomy, capsulotomy, complications, and use of intraocular lenses (IOLs). Postoperative data included final visual acuity, refraction, number of follow-up visits, and program support for follow-up.

RESULTS:

Of 574 eyes of 415 children (mean age 7.1 years +/- 4.7 [SD]), IOLs were placed in 416 (87%). At least 1 follow-up was attended by 408 patients (98.3%) (mean total follow-up 3.5 +/- 1.8 months); 40% of eyes achieved a final visual acuity of 6/18 or better. Children living farther from the hospital had fewer postoperative visits (P = .04), while children receiving program support had more visits (P = .001). Factors predictive of better acuity included receiving an IOL during surgery (P = .04) and provision of postoperative spectacles (P = .001). Predictive of worse acuity were amblyopia (P = .003), postoperative complications (P = .0001), unilateral surgery (P = .0075), and female sex (P = .045).

CONCLUSIONS:

The results underscore the importance of surgical training in reducing complications, early intervention before amblyopia (observed in 40% of patients) can develop, and vigorous treatment if amblyopia is present. The positive impact of program support on follow-up is encouraging, although direct financial support may pose a problem for sustainability. More work is needed to understand reasons for worse outcomes in girls.

Visual outcomes and astigmatism after sutureless, manual cataract extraction in rural China: study of cataract outcomes and up-take of services (SCOUTS) in the caring is hip project, report 1.

OBJECTIVE: To study the visual acuity and astigmatism of persons undergoing cataract extraction by local surgeons in rural China. METHODS: Visual acuity, keratometry, and refraction were measured 10 to 14 months postoperatively for all cataract cases during 4 months in Sanrao, China. RESULTS: Among 313 eligible subjects, 242 (77%) could be contacted, of whom 176 (73%) were examined. Of those who were examined, mean +/- SD age was 69.3 +/- 10.5 years, 66.5% were female, 35 had been operated on bilaterally at Sanrao, and 85.2% had a preoperative presenting visual acuity of 6/60 or worse. Presenting and best-corrected postoperative acuity in the eye that was operated on were 6/18 or better in 83.4% and 95.7%, respectively. Among 27 fellow eyes operated on elsewhere, 40.7% had a presenting acuity of 6/18 or better and 40.7% were blind (P < .001). Mean +/- SD postoperative astigmatism did not differ between 211 eyes that were operated on (-1.13 +/- 0.84 diopters) and 109 eyes that were not (-1.13 +/- 1.17 diopters; P = .27). Presence of operative complications (8.5%) and older age were associated with worse vision; bilateral surgery was associated with better vision. CONCLUSIONS: These results confirm the effectiveness of skill transfer in this setting, with superior outcomes to most studies in rural Asia and to eyes in this cohort operated on at other facilities.

Endothelial cell loss and surgically induced astigmatism after sutureless large-incision manual cataract extraction (SLIMCE).

OBJECTIVES:

To describe a modified manual cataract extraction technique, sutureless large-incision manual cataract extraction (SLIMCE), and to report its clinical outcomes.

METHODS:

Case notes of 50 consecutive patients with cataract surgery performed using the SLIMCE technique were retrospectively reviewed. Clinical outcomes 3 months after surgery were analyzed, including postoperative uncorrected visual acuity, best-corrected visual acuity, intraoperative and postoperative complications, endothelial cell loss, and surgically induced astigmatism using the vector analysis method.

RESULTS:

At the 3-month follow-up, all 50 patients had postoperative best-corrected visual acuity of at least 20/60, and 37 patients (74%) had visual acuity of at least 20/30. Uncorrected visual acuity was at least 20/68 in 28 patients (56%) and was between 20/80 and 20/200 in 22 patients (44%). No significant intraoperative complications were encountered, and sutureless wounds were achieved in all but 2 patients. At the 3-month follow-up, endothelial cell loss was 3.9%, and the mean surgically induced astigmatism was 0.69 diopter.

CONCLUSIONS:

SLIMCE is a safe and effective manual cataract extraction technique with low rates of surgically induced astigmatism and endothelial cell loss. In view of its low cost, SLIMCE may have a potential role in reducing cataract blindness in developing countries.

Cataract surgical outcomes, visual function and quality of life in four rural districts in Vietnam.

BACKGROUND: To evaluate cataract surgical outcomes in four rural districts of Ha Tinh Province, Vietnam. DESIGN: Cross-sectional study. PARTICIPANTS: Post-cataract surgery patients sampled randomly from facilities in four rural districts of Ha Tinh Province >3 months after surgery. MAIN OUTCOME MEASURES: Postoperative visual acuity (VA), visual function and quality of life. RESULTS: Among 412 patients, the mean age was 74.5 ± 9.4 years, 67% (276) were female, and 377 (91.5%) received intraocular lenses (IOL). Nearly two-thirds of patients had no postoperative visits after discharge. Postoperatively, more than 40% of eyes had presenting VA <6/18, while 20% remained <6/60. The mean self-reported visual function and quality of life for all patients were 68.7 ± 23.8 and 73.8 ± 21.6, respectively. Most patients (89.5%) were satisfied with surgery and the majority (94.4%) would recommend surgery to others. One-third of patients paid ≥$US50 for surgery. In multiple regression modelling, older age (P < 0.01), intraoperative complications (P < 0.01) and failure to receive an IOL (P < 0.01) were associated with postoperative VA <6/60. CONCLUSION: Satisfaction with surgery was high, and many patients were willing to pay for their operations. Poor visual outcomes were common; however, and better surgical training is needed to reduce complications and their impact on visual outcomes. More intensive postoperative follow-up may also be beneficial. © 2011 The Authors. Clinical and Experimental Ophthalmology © 2011 Royal Australian and New Zealand College of Ophthalmologists.