Laser Resistance of Endotracheal Tubes I: Experimental Results of a Compound Tube in Comparison to a Metallic Tube

Laser-induced ignition of endotracheal tubes is a serious problem in CO₂ laser surgery of the upper aerodigestive tract. A new tube built of composite materials with a foam at its surface is protected by vaporisation of water from the wet foam. This tube and a flexible metallic tube of stainless steel were tested experimentally against the radiation of various lasers such as CO₂, holmium/YAG, Nd/YAG, Nd/YAG frequency doubled in KD*P, argon and excimer. At laser power densities of 10³ W/cm², the shaft of the metallic tube was damaged within seconds whereas the compound tube was stable for more than 2 min; the damage threshold of the new tube was found to be at 3.2×10⁶ W/cm². While the compound tube was found to be sufficiently laser resistant, the metallic tube was found to exhibit functional damage, in particular the PVC inflation conduits inside of the tube were destroyed. Received for publication 13 June 1997; accepted following revision 16 February 1998     

Laser Myringotomy (L-Myringotomy) and Ventilating Tubes: A Preliminary Comparative Study

A prospective comparative study was done to assess the validity of laser myringotomy (L-myringotomy) when compared to the insertion of ventilating tubes (VT). In 23 children with chronic otitis media with effusion, a VT was inserted in the left ear while a laser myringotomy was performed in the right ear by using the CO₂ Sharplan 1030 laser. After a six month follow-up conducted during the winter months, the results with the laser myringotomy were equal to those in the left ear with the VT. During the follow-up period, three ears required additional laser myringotomy either for early closure or because of otitis media and the accumulation of effusion in the middle ear cavity. Nevertheless, the use of laser has the advantage that there is no foreign body in the ear, the tympanic membrane is closed after four to seven weeks, and since the procedure is very short, the time for anaesthesia is minimal. Paper received 17 November 1997; accepted after revision 13 May 1998.     

Diffusing Fibre Tip for the Minimally Invasive Treatment of Liver Tumours by Interstitial Laser Coagulation (ILC): An Experimental Ex Vivo Study

A newly developed diffusing laser applicator was examined for interstitial laser coagulation (ILC) of liver tumours. The applicator consisted of a matted quartz core and a quartz glass dome, also matted on its inner surface and sealed to the fibre. The applicator provided a homogeneous light intensity distribution over an active length of about 20 mm. Lesions were created in an ex-vivo porcine liver model using a Nd-YAG laser comparing the new diffusing tip with a Ringmode^?-ITT applicator in order to find optimal laser parameters and damage thresholds. The lesions were investigated using macroscopic size measurement, volume calculation and histological examination (H&E, NADPH-dehydrogenase). The damage threshold of the diffusing tip was 6 W at 14 min exposure time whereas the Ringmode^?-ITT applicator had its limit at 5 W and 12 min exposure. Comparing various exposure times showed that treatment over a time of more than 840 s did not significantly increase the lesion volume. At 5 W and 720 s the mean lesion volume was 6.9±1.1 cm³ with the diffusing tip and 6.3±0.6 cm³ with the Ringmode^?-ITT applicator, both having a slight ellipsoidal shape. Hence, the created lesions were not significantly different for both applicators when the same laser parameters were applied. On the other hand, the new diffusing tip had a higher damage threshold and was therefore capable of producing maximal coagulation volumes of up to 7.9±0.5 cm³ at 5 W and 20 min. The experiments showed that lesions with a dimension of 31×22 mm can be achieved with the diffusing applicator which seem suitably sized for treating small human liver metastases in a single laser session. Paper received 25 April 1997; accepted after revision 13 March 1998.     

Eraser Laser Enucleation of the Prostate: Technique and Results

Background

Eraser, a 1318-nm diode laser, has been used for 15 yr for resection of lung metastases. It was recently introduced in urology for small kidney tumors and for the treatment of benign prostatic obstruction.

Objective

To demonstrate on video our technique of Eraser laser enucleation of the prostate (ELEP) and report our experience.

Design, setting, and participants

From June 2010 to October 2011, 43 consecutive patients were prospectively evaluated. All of them had lower urinary tract symptoms suggestive of benign prostatic obstruction and a mean prostate size of 59.9 ml (range: 34–89 ml) on transrectal ultrasound. Their mean prostate-specific antigen value was 3.4 ng/ml (range: 0.8–5.0 ng/ml); mean maximum flow rate (Q_max), 6.9 ml/s (range: 2–11 ml/s); mean International Prostate Symptom Score (IPSS), 25.9 (range: 18–32); and mean postvoid residual (PVR), 170.5 ml (range: 60–330 ml).

Surgical procedure

The details of the technique are shown on video.

Outcome measurements and statistical analysis

Success was defined as patients being able to void with improved IPSS, Q_max, PVR volume, and ameliorated quality of life.

Results and limitations

The mean operating time was 67.0 ± 11.43 min. Mean serum hemoglobin was 15.1 ± 0.87 g/l before, and 14.39 ± 0.94 g/l after surgery. Mean blood loss was 115.90 ± 98.12 ml. No blood transfusions were required. All patients had their catheters removed within 2 d and were able to void spontaneously after this time. Significant improvements were noted in Q_max, quality of life, IPSS, and PVR volume from baseline to each follow-up time point.Based on the validated Clavien-Dindo system, we observed one grade 1d complication, one grade 2 complication, and one grade 3b complication.

Conclusions

ELEP is a safe and reproducible method for relieving bladder outflow obstruction and lower urinary tract symptoms. Its advantages include minimal blood loss, short catheterization time, and a brief hospital stay.     

Holmium: YAG Laser Resection of the Prostate Versus Visual Laser Ablation of the Prostate and Transurethral Ultrasound-Guided Laser Induced Prostatectomy: A Retrospective Comparative Study

Background:
Transurethral resection of the prostate (TUR-P) is the gold standard for treating symptomatic benign prostatic hyperplasia (BPH) despite some perioperative morbidity. As a minimally-invasive alternative to TUR-P, a neodymium:YAG laser, and more recently a holmium:YAG laser, have been used in transurethral surgery for BPH. In order to assess the safety and efficacy of various BPH treatments, the outcome in patients treated with transurethral ultrasound-guided laser induced prostatectomy (TULIP), visual laser ablation of the prostate (VLAP) and holmium:YAG laser resection of the prostate (HoLRP) were retrospectively compared.
Methods:
From May 1995 to August 1996, 60 patients with symptomatic BPH underwent TULIP (n=20), VLAP (n=20), and HoLRP (n=20). All patients were evaluated preoperatively and at 1 and 3 months postoperatively by the International Prostate Symptom Score (IPSS), the IPSS quality-of-life score (QOL), maximum flow rate (MFR), prostate volume, and residual urine volume.
Results:
The preoperative mean IPSS was 18.5, 19.3, and 19.6 and the mean MFR was 6.3, 6.9, and 6.1mL/sec in the TULIP, VLAP, and HoLRP groups, respectively. At 1 month after surgery, the mean IPSS was 10.2, 9.5, and 4.7 and the mean MFR was 9.6, 1 3.4, and 1 8.7mL/sec while at 3 months the mean IPSS was 6.2, 6.1, and 3.6 and the mean MFR was 14.1, 1 6.0, and 21.5 mL/sec in patients treated with TULIP, VLAP, and HoLRP, respectively. No serious complication occurred in any patient.
Conclusion: Although HoLRP requires expertise, it appears to be a promising treatment modality for BPH.     

The Influence of Low Intensity Infrared Laser Irradiation on Conduction Characteristics of Peripheral Nerve: A Randomised,Controlled, Double Blind Study on the Sural Nerve

. The aim of this study was to investigate the effects of low intensity laser therapy (LILT) on the conduction characteristics of peripheral sensory nerve. Fifteen healthy subjects participated in this experiment. Six points on the sural nerve of the left leg were irradiated with an 830 nm GaAlAs laser with different parameters. All 15 subjects received at random one of the following treatments: an average power of 400 mW at a dose of 1.5 J per point (7.65 J/cm²) (treatment A); an average power of 140 mW and a dose of 1.0 J per point (5.1 J/cm²) (treatment B); an average power of 30 mW, 0.5 J per point (2.55 J/cm²) (treatment C) and to evaluate possible placebo effects in a fourth moment, no power was given (sham). The influence of skin temperature on conduction characteristics of peripheral nerve was taken into account by using correction factors for conductance velocity (1.47 m/s per °C) and negative peak latency (0.2 ms per °C) to a reference temperature of 32°C. One way analysis of variation with repeated measurements of the data collected within 15 min postirradiation showed a significant decrease in conduction velocity and increase in negative peak latency in treatment B. Those results could explain possible laser-mediated pain relief. Paper received 3 August 1999; accepted after revision 19 October 1999.     

Monitoring of Interstitial Laser Thermotherapy with Heat-sensitive Colour Subtraction Magnetic Resonance Imaging: Calibration with Absolute Tissue Temperature and Correlation with Predicted Lesion Size

. Magnetic resonance imaging (MR) is the most sensitive modality for monitoring interstitial thermotherapy (ILT). A real-time pulse sequence that assigns a colour spectrum to grey-scale changes could potentially increase the accuracy of MR-guided thermal surgery. This study aimed to calibrate this sequence with tissue temperature and then to determine whether it could be used to predict accurately the extent of tissue necrosis produced during the formation of a thermal lesion. Porcine livers were studied within a 0.5T Interventional MR Unit. A Nd:YAG laser fibre (λ=1064 nm) with a diffuser tip was placed within the liver parenchyma adjacent to an MR compatible thermocouple. A template sagittal MR image containing the fibre tip was obtained. A 3 cm region of interest (ROI) was centred on the fibre. Thermal lesions were produced (5 W for 20 min) with real-time subtraction MR monitoring with colour overlay throughout (acquisition time 4 s). At 60 s intervals the pixel intensity value, temperature and colour at the laser tip were noted. Twenty burns were produced. Pixel intensity measurements were expressed as percentages of mean pixel intensity within the ROI to standardise measurements. Using the colour representing the temperature above which tissue necrosis would be expected to occur, predicted maximum lesion size was measured from the images and compared with histological assessment. There was a linear relationship between temperature and percentage pixel change (r ²= 0.84). Six discrete colours were determined, all significantly different from each other in terms of mean percentage pixel change (p<0.01) and mean temperature (p<0.01 except between orange and yellow, p=0.037). Green had a mean temperature of 55.6 (±5)°C, and thus predicted necrosis. Image-predicted maximum lesion size correlated closely with histology (r ²=0.93). The colour changes produced by this unique pulse sequence have been calibrated with tissue temperature in vitro. The green colour represents the temperature above which necrosis would be expected to occur and can be used to accurately predict lesion size. This will potentially allow greater accuracy and safety for MR monitoring of ILT in vivo. Paper received 16 September 1997; accepted after revision 18 March 1999.     

Resurfacing of Pitted Facial Acne Scars Using Er:YAG Laser with Ablation and Coagulation Mode

Although the conventional, short-pulsed erbium: yttrium-aluminum-garnet (Er:YAG) laser provides substantial clinical improvement for pitted, facial acne scars, it shows less effective hemostasis and limited residual thermal effect in the dermis. Recently, dual-mode Er:YAG laser systems with both ablation and coagulation modes have been developed. The purpose of this study was to evaluate the clinical and histologic effects of resurfacing pitted, facial acne scars with a dual-mode Er:YAG laser. Twenty patients with pitted facial acne scars underwent laser resurfacing using a computerized-scanning, dual-mode Er:YAG laser. All patients had Fitzpatrick skin types ranging III–V. Initially, the epidermis was removed in two passes using the ablative settings. This step was followed by two passes in a mixed ablation and coagulation mode, to produce further ablation and controlled, residual thermal damage. A final pass in a ablation mode was used to remove necrotic tissue. Laser overlapping was approximately 30%. The results of laser treatment were evaluated for the degree of clinical improvement, duration of erythema, pigmentary change, and any adverse events at two weeks, one month, and three months. In two patients, skin biopsies were obtained at the following intervals: immediately and two weeks postoperatively for histologic examination. There was a 75% average clinical improvement observed in pitted, facial acne scars after laser treatment. Complete wound healing occurred between six and eight days. On histologic examination, complete re-epithelialization was observed at two weeks. Erythema occurred in all patients after laser treatment and lasted longer than three months in 10 patients (50%). Post-inflammatory hyperpigmentation occurred in 12 patients (60%) two to four weeks after laser treatment and lasted longer than three months in one patient (5%). One patient (5%) experienced mild hypopigmention. Mild to moderate, postoperative acne flare-up occurred in seven patients (35%). No other adverse effects were observed. In conclusion, resurfacing with a dual-mode Er:YAG laser is a safe and effective treatment modality for pitted, facial acne scars.     

Holmium-YAG Laser ablation characteristics in calvarial lamellar and cortical bone: The role of water and tissue micro-architecture

The effect of tissue micro-architecture and water content on ablation rates in bone is examined. Precisely machined and prepared porcine calvarial lamellar and cortical bone were ablated with a Holmium-YAG laser (=2.1m). Lamellar and cortical bone differ substantially in their tissue micro-architecture. Both are porous hard tissues, which differ predominantly in size and distribution of pores within the bone matrix. These hard tissues were ablated under physiological (wet) and chemically dehydrated conditions. The ablation rates over the range of energy densities examined assumes many linear characteristics. Ablation rate (as a function of fluence) is considerably higher for dehydrated cortical bone (4.7m cm² J^–1) compared to fresh cortical bone (1.49m cm² J^–1). This trend is also observed in lamellar bone (2.31m cm² J^–1 for wet and 0.37m cm² J^–1 for dry). Under both physiological and dehydrated conditions, cortical bone was ablated faster. Mechanisms accounting for these observations are discussed.     

1064-nm Nd:YAG皮秒点阵激光与超脉冲CO2点阵激光治疗面部萎缩性痤疮瘢痕的临床比较

目的 探究1064-nm Nd:YAG皮秒点阵激光与超脉冲CO2点阵激光治疗面部萎缩性痤疮瘢痕的疗 效与安全性。方法 选取2021年6月-2023年6月于我院激光科接受治疗的62例面部萎缩性痤疮瘢痕患者作 为研究对象,按照不同的治疗方法分为皮秒点阵激光组和CO2点阵激光组,各31例。皮秒点阵激光组给予 1064-nm Nd:YAG皮秒点阵激光治疗,CO2点阵激光组给予超脉冲CO2点阵激光治疗,比较两组ECCA权 重评分、疗效自评分、满意度评分及术后不良反应发生情况。结果 两组治疗后ECCA权重评分均较治疗 前降低（P ＜0.05）,且皮秒点阵激光组的ECCA权重评分高于CO2点阵激光组（P ＜0.05）;CO2点阵激光 组疗效自评分高于皮秒点阵激光组（P ＜0.05）;皮秒点阵激光组不良反应发生情况低于CO2点阵激光组 （P ＜0.05）;两组满意度比较,差异无统计学意义（P＞0.05）。结论 1064-nm Nd:YAG皮秒点阵激光与 超脉冲CO2点阵激光均能有效改善面部萎缩性痤疮瘢痕,超脉冲CO2点阵激光疗效更好,而皮秒点阵激光 不良反应发生情况更少。     

Results of fractional ablative facial skin resurfacing with the erbium:yttrium-aluminium-garnet laser 1 week and 2 months after one single treatment in 30 patients

The erbium:yttrium-aluminium-garnet (Er:YAG) laser has recently been used in the fractional resurfacing of photo-aged skin. Our study evaluated the results after one single session of fractional resurfacing with Er:YAG. Thirty women participated in the study, with an average age of 46 years, skin types from II to IV, and wrinkle grades I to III. The 2,940 nm Er:YAG system used (Pixel, Alma Laser, Israel) had variable pulse durations (1 ms to 2 ms) and energy densities (800 mJ/cm(2) to 1,400 mJ/cm(2)) which, together with the number of passes (four to eight), were selected as a function of wrinkle severity. All patients received only one treatment. Postoperative side effects were evaluated. The number of wrinkles was documented with clinical photography and was scored. Histological assessment was carried out on two patients before and 2 months after treatment. All patients completed the study. Of the patients, 93% reported good or very good improvement of the degree of their wrinkles, with a satisfaction index of 83%. Pain was not a problem during treatment, and there were no side effects except for in one phototype IV patient, who had hyperpigmentation. Histology 2 months after the single treatment demonstrated younger morphology of both the epidermis and dermis, with improvement of the pretreatment typical elastotic appearance. At the parameters used in our study, only one treatment session of Er:YAG laser could achieve effective skin rejuvenation, with effects recognized in both the dermis and, more importantly, the epidermis. This regimen offers an interesting alternative to the conventional approach of multi-session fractional resurfacing.     

Efficacy and Safety of Q-switched Double-frequency 532-nm Neodymium-doped Yttrium Aluminum Garnet Laser in the Treatment of Lip Hyperpigmentation: A Pilot Study

BackgroundLip hyperpigmentation is a common cosmetic problem with multiple causative factors and limited treatment options.ObjectiveThis study sought to assess the efficacy and safety of Q-switched (QS) double-frequency 532-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser therapy for dark lips.MethodsA prospective pilot study of 24 patients with lip hyperpigmenation treated with a QS double-frequency 532-nm Nd:YAG laser was performed. Photographs taken before and three months after the laser therapy sessions were evaluated for improvement and/or any complication by two blinded dermatologists using the color score chart and a visual analog scale (VAS). Patients were asked to assess their pain and satisfaction scores following the procedure using a VAS.ResultsThe mean VAS scores of the photographs decreased by 10.18 percent, from a baseline of 6.09±1.53 to 5.47±1.72 (p=0.16). Also, the color score decreased by 9.38 percent, from 2.44±0.61 to 2.23±0.71 points (p=0.23) after the last treatment. Overall, the photographic assessment indicated that, of the 24 participants, 14 (58.3%) showed moderate to excellent improvement, four (16.7%) showed mild or no improvement, and six (25.0%) showed worsening/mottling of the pigmentation. The overall mean pain and satisfaction scores were 4.08±1.14 and 6.50±2.92, respectively.ConclusionQS Nd:YAG 532-nm laser therapy appears to be a safe and moderately effective treatment for hyperpigmentation of the lips. Further studies should evaluate a larger number of patients and undertake a longer period of follow-up.     

Treatment of cutaneous vascular lesions using multiple-intermittent cryogen spurts and two-wavelength laser pulses: numerical and animal studies

BACKGROUND AND OBJECTIVES: Presently, cutaneous vascular lesions are treated using a single cryogen spurt and single laser pulse (SCS-SLP), which do not necessarily produce complete lesion removal in the majority of patients. In this study, the feasibility of applying multiple cryogen spurts intermittently with multiple two-wavelength laser pulses (MCS-MTWLP) was studied using numerical and animal models. STUDY DESIGN/MATERIALS AND METHODS: Two treatment procedures were simulated: (1) SCS+532 nm SLP; and (2) MCS+532/1064 nm MTWLP. Light transport and heat diffusion in human skin were simulated with the Monte Carlo method and finite element model, respectively. Possible epidermal damage and blood vessel photocoagulation were evaluated with an Arrhenius-type kinetic model. Blood vessels in the rodent window chamber model (RWCM) were irradiated with either SLP or MTWLP. Laser-induced structural and functional changes in the vessels were documented by digital photography and laser speckle imaging (LSI). RESULTS: The numerical results show that the MCS-MTWLP approach can provide sufficient epidermal protection while simultaneously achieving photocoagulation of larger blood vessels as compared to SCS-SLP. Animal studies show that MTWLP has significant advantages over SLP by inducing irreversible damage to larger blood vessels without adverse effects. CONCLUSIONS: MCS-MTWLP may be a promising approach to improve therapeutic outcome for patients with cutaneous vascular lesions featuring large blood vessels.     

Surgical Education to Improve the Quality of Patient Care: the Role of Practice-Based Learning and Improvement

Health care is going through immense change, and concerns regarding the quality of patient care and patient safety continue to be expressed in many national forums. A variety of stakeholders are demanding greater accountability from the health care profession. Education is key to supporting surgeons’ efforts to provide high-quality patient care during these challenging times. Educational programs for surgeons should be founded on principles of continuous professional development (CPD) and practice-based learning and improvement (PBLI). CPD focuses on the specific needs of individual surgeons and involves lifelong learning throughout a surgeon’s career. It needs to form the basis of PBLI efforts. PBLI involves a cycle of four steps—identifying areas for improvement, engaging in learning, applying new knowledge and skills to practice, and checking for improvement. Ongoing involvement in PBLI activities to address specific learning needs should positively impact a surgeon’s practice and improve outcomes of surgical care.     

The Surgical Treatment of Type II Diabetes Mellitus: Changes in HOMA Insulin Resistance in the First Year Following Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) and Laparoscopic Adjustable Gastric Banding (LAGB)

Background  Bariatric operations significantly improve glucose metabolism, decrease insulin resistance, and lead to clinical resolution of type II diabetes mellitus in many patients. The mechanisms that achieve these clinical outcomes, however, remain ill defined. Moreover, the relative impact of various operations on insulin resistance remains vigorously contested. Consequently, the purpose of this study was to compare directly the impact of laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic adjustable gastric banding (LAGB) on hemoglobin A1c (HbA1c) levels and insulin resistance in comparable groups of morbidly obese patients. Methods  Data were entered prospectively into our bariatric surgery database and reviewed retrospectively. Patients selected operations. Principle outcome variables were percent excess weight loss (%EWL), HbA1c, and homeostatic model assessment for insulin resistance (HOMA IR). Results  The number of follow-up visits for 111 LAGB patients was 263 with a median of 162 days (17–1,016) and 291 follow-up visits for 104 LRYGB patients for a median of 150 days (8–1,191). Preoperative height, weight, body mass index, age, sex, race, comorbidities, fasting glucose, insulin, HbA1c, and HOMA IR were similar for both groups. In particular, the number of patients who were diabetics and those receiving insulin and other hypoglycemic agents were similar among the two groups. The LAGB patients lost significantly less weight than the LRYGB patients (24.6% compared to 44.0% EWL). LAGB reduced HbA1c from 5.8% (2–13.8) to 5.6% (0.3–12.3). LRYGB reduced HbA1c from 5.9% (2.0–12.3) to 5.4% (0.1–9.8). LAGB reduced HOMA IR from 3.6 (0.8–39.2) to 2.3 (0–55) and LRYGB reduced HOMA IR from 4.4 (0.6–56.5) to 1.4 (0.3–15.2). Postoperative HOMA IR correlated best with %EWL. Indeed, regression equations were essentially identical for LAGB and LRYGB for drop in %EWL versus postoperative HOMA IR. Conclusion  Percent excess weight loss significantly predicts postoperative insulin resistance (HOMA IR) during the first year following both LRYGB and LAGB.     

Assessment of three year experience of a strategy for patient selection and timing of operation in the management of acute thoracic and lumbar spine fractures: a prospective study

Summary Background. The purpose of this article is to report experience gained over three years of the use of a protocol for patient selection and timing of operation for acute thoracic and lumbar fractures. Method. At admission, all patients underwent neurological and imaging exams. All patients with a spinal cord lesion scored as ASIA A at any level inferior to T10 and as ASIA B, C or D at any level, were categorized as emergency and operated on within eight hours from trauma. ASIA A cases in the T1–T10 tract and ASIA E cases at any level were treated in the ordinary operative work schedule. Findings. Ninety-four patients with surgically treated lumbar or thoracic fractures took part in this study. On the imaging studies, 12 patients were classified as A, 50 as B and 32 as C following the AO classification. At the neurological exam, 39 patients were scored as ASIA A, nine as B, six as C, two as D and 38 as E. At follow-up, of the 39 patients scored as ASIA A, 13 (33%) improved at least one grade and of the 17 scored as ASIA B, C or D, 11 (64.7%) improved. None of the 38 patients scored as ASIA E deteriorated. Conclusions. The findings show that the strategy in the protocol was safe and followed by satisfactory rates of neurological outcome. Larger prospective studies, preferably randomized, are needed to establish definitively its place in the management of patients with spinal injury.     

Phase II trial of tesmilifene plus mitoxantrone and prednisone for hormone refractory prostate cancer: high subjective and objective response in patients with symptomatic metastases

PURPOSE: Symptomatic, hormone refractory prostate cancer (HRCAP) is a major cause of morbidity with a median survival of less than 12 months and a 2-year survival of only up to 10% in most series. Mitoxantrone has been approved by the Food and Drug Administration for HRCAP. Preliminary data suggest that DPPE (N,N-diethyl-2-[4-(phenylmethyl) phenoxy]-ethanamine) or tesmilifene modulates cytotoxics to enhance the anticancer effect. In this phase II trial we assessed whether there is sufficient evidence of enhanced efficacy of DPPE and mitoxantrone to lead to a phase III clinical trial. MATERIALS AND METHODS: A total of 29 patients with a median age of 73 years, of whom 10% were older than 80 years, with progressive HRCAP received 5.3 mg/kg DPPE intravenously every 3 weeks, 12 mg/m mitoxantrone intravenously every weeks and 5 mg prednisone orally twice daily. All patients had pain at presentation, while 97% had bone metastases, 10% had liver metastases and 17% had lung metastases. Median prostate specific antigen (PSA) was 210 ng/ml (IQR 77 to 430). RESULTS: Of the patients 75% had some pain improvement, 66% had decreased analgesia, 59% had a PSA decrease of 50% or greater and 45% had a PSA decrease of 75% or greater. Actual (not actuarial) 2-year survival was 21%. CONCLUSIONS: Despite major limitations of historical comparison the PSA decrease and decreased symptoms with DPPE-mitoxantrone-prednisone compare favorably to those of mitoxantrone-prednisone and docetaxel-estramustine in the literature. The 2-year survival rate of 21% mandates further assessment. This will be tested in a phase III Southwest Oncology Group trial.     

Efficacy of neoadjuvant treatment with or without pertuzumab in patients with stage II and III HER2-positive breast cancer: a nationwide cohort analysis of pathologic response and 5-year survival

BackgroundPathologic complete response (pCR) rates in early stage HER2-positive breast cancer improved after pertuzumab was added to neoadjuvant treatment. However, survival benefit is less-well established and seems mostly limited to node-positive patients. We used national cancer registry data to compare outcomes of patients treated with and without pertuzumab.MethodsWe identified stage II-III HER2-positive breast cancer patients treated with neoadjuvant trastuzumab-based chemotherapy between November 2013 until January 2016 from the Netherlands Cancer Registry. During that period pertuzumab was only available in the 37 hospitals that participated in the TRAIN-2 study. Missing grade and pCR-status were obtained from the Dutch Pathology Registry (PALGA) and cause of death from Statistics Netherlands. We used multiple imputation to impute missing data, multivariable logistic regression to evaluate the association between pertuzumab and pCR (ypT0/is, ypN0) and multivariable Cox regression models for overall survival and breast cancer specific survival (BCSS).ResultsWe identified 1124 patients of whom 453 received pertuzumab. Baseline characteristics were comparable, although tumor grade was missing more often in patients treated without pertuzumab (12% vs. 2%). Pertuzumab improved pCR rates (41% vs 65%, adjusted odds ratio [aOR] 2.91; 95% CI:2.20–3.94). After a median follow-up of 6.0 years, 5-year BCSS rates were 95% and 98% respectively (adjusted hazard ratio [aHR]: 0.58; 95% CI:0.36–0.95). Younger patients derived more benefit from pertuzumab, but no other significant interactions were found.ConclusionThese results support earlier data of a small survival benefit with the addition of pertuzumab to trastuzumab-based neoadjuvant chemotherapy which is most meaningful in younger patients.