Failure properties of 352 explanted silicone-gel breast implants

1996 ◽  
Vol 4 (1) ◽  
pp. 1-8 ◽  
Author(s):  
Walter Peters ◽  
Dennis Smith ◽  
Stanley Lugowski
Keyword(s):  
First Generation ◽  
Second Generation ◽  
Survival Curve ◽  
Breast Implants ◽  
Thick Wall ◽  
Thin Wall ◽  
Third Generation ◽  
Silicone Gel ◽  
Failure Properties

There have been three generations of silicone-gel breast implants. First generation implants (thick wall – thick gel with Dacron patches) were made from 1963 to 1972. Second generation implants (thin wall-thin gel) were made from 1972 until the mid 1980s. The introduction of third generation implants (stronger wall, low-bleed) was geographically dependent. In Canada, Dow Corning Silastic II implants were introduced in 1986, and Surgitek SCL implants were introduced in 1988. In the present study, a total of 352 silicone-gel breast implants were removed from 239 patients between 1981 and 1995. Their failure properties were dependent upon their generation (year of manufacture) and, for second generation implants, their duration in situ. Of the 352 implants, 20 were first generation, and all were fully intact. Twenty-eight were third generation implants, and 27 were fully intact. Failure properties of the 302 second generation implants were dependent upon their duration of implantation. A survival curve indicated that these implants began to fail (by leaking or rupturing) after four years in situ. By six years, 40% had failed. After 12 years, 95% had failed. Of the 171 second generation implants removed between 1991 and 1995, 77% had failed. The failure properties were similar for the three main manufacturers: Dow Corning, Heyer-Schulte and Surgitek. The failure rate for second generation implants is much higher than was previously believed. This is particularly significant in view of the current difficulty in diagnosing implant failure.

Current Status of Breast Implant Survival Properties and the Management of the Woman with Silicone Gel Breast Implants

2000 ◽  
Vol 8 (2) ◽  
pp. 54-67 ◽  
Author(s):  
Walter Peters
Keyword(s):  
Breast Cancer ◽  
First Generation ◽  
Second Generation ◽  
Imaging Modality ◽  
Capsular Contracture ◽  
Breast Implants ◽  
Current Status ◽  
Third Generation ◽  
Silicone Gel

The survival properties of silicone gel breast implants are dependent on their vintage (year of manufacture), duration in situ and manufacturer. A total of 527 gel implants have been explanted and analyzed in the author's laboratories. Of the 28 first-generation implants (1963 to 1972), 27 (96.4%) remained intact after 14 to 28 years in situ (mean 20.8 years). Of the 216 second-generation implants (1973 to mid-1980s) that were explanted from 1992 to 1998, 158 (73%) had disrupted. Kaplan-Meier survival curves demonstrated significantly different survival properties among second-generation manufacturers. Surgitek implants were by far the least durable. After 14 years, all second-generation Surgitek implants had disrupted. By contrast, after 20 years, about half of the Dow Corning and Heyer-Schulte implants remained intact. Among third-generation implants (mid-1980s to 1992), 43 of 46 (93.4%) remained intact after a mean of 6.3 years (range three to 12 years). The three disruptions were Surgitek implants. Implants from other manufacturers remained intact. However, the disruption frequencies of third-generation implants have yet to be measured over the relevant periods of time. Survival patterns appeared to be related to the thickness of the elastomeric shell of the three generations of implants. Mechanical strength analyses of the elastomeric shells of explants have exhibited little or no large scale material degradation, even after as long as 28 years in situ. The mechanism of implant disruption likely involves the ‘fold flaw’ theory, whereby an internal abrasion can develop over time at the site of a fold in the implant wall. Diagnosis of disruption is difficult. Mammography is helpful only if there has been extravasation of silicone gel into breast tissue. Extravasation was observed in only 4.2% of second-generation implants removed from 1992 to 1998. It was not seen with first- or third-generation implants. Ultrasound analyses are not generally helpful to predict disruption because they are very operator dependent and because capsular contracture causes folds in the implant wall, which result in false positives. Magnetic resonance imaging is the most accurate imaging modality to detect implant disruption. However, this technology is not indicated for monitoring implant status because it is too costly and time consuming, and because it has significant limitations, particularly with first-generation and textured implants. Careful explantation and direct visual examination are the standards for diagnosing gel implant disruption. Many implant disruptions are likely ‘silent’, with no specific symptoms or clinical findings. After disruption, none of the following are elevated above the levels seen in control women without implant exposure: serum autoantibodies, blood and serum silicon, and the incidence of breast cancer, autoimmune disease or any other medical disease. There is no evidence to support the existence of any ‘novel’ or ‘atypical’ syndrome associated with gel implants. Women over 30 years of age with breast implants require regular monitoring for breast cancer detection. This should include monthly breast self examination and annual clinical breast examination. In addition, women over 50 years old require annual eight-view mammographic assessment using the implant displacement technique. Even then, breast implants have been shown to interfere with complete imaging, particularly if the implants are subglandular, large or associated with significant capsular contracture. A logical approach to explantation should involve consideration of a patient's personal concerns and anxiety, her implant vintage, the plane of insertion of her implants, her current clinical status and whether she chooses to replace her gel implants. Women requesting explantation require extensive information before deciding on surgery. At explantation, capsulectomy seems to be indicated if there is capsular calcification or major capsular thickening. (Pour le résumé, voir page suivante)

Survival properties of third-generation silicone gel breast implants

2002 ◽  
Vol 10 (3) ◽  
pp. 109-112 ◽  
Author(s):  
Walter Peters ◽  
Stanley Lugowski
Keyword(s):  
Breast Augmentation ◽  
Second Generation ◽  
Breast Implants ◽  
Health Problems ◽  
Third Generation ◽  
Survival Curves ◽  
Medical Disease ◽  
Silicone Gel ◽  
Kaplan Meier ◽  
Implant Size

From 1992 through 2001, 100 third-generation silicone gel breast implants were removed from 50 women who had undergone cosmetic breast augmentation. The main reasons for explantation were: ptosis in 16 patients (32%); to further increase implant size in 15 patients (30%); suspected silicone-related health problems in 11 patients (22%); medical disease in five patients (10%); and breast firmness and pain in three patients (6%). Of the 100 third-generation gel implants, 42 were manufactured by McGhan Medical, 38 by Surgitek, 10 by Cox-Uphoff and 10 by Dow Corning. The 42 McGhan implants had been in place for two to 15 years (mean 8.8 years), the 10 Cox-Uphoff implants for seven to 14 years (mean 9.4 years), and the 10 Dow Corning implants for five to 12 years (mean 8.1 years). All the McGhan, Cox-Uphoff and Dow Corning implants were clinically intact at explantation. By contrast, of the 38 Surgitek third-generation implants, which had been in place for three to 13 years (mean 7.9 years), only 28 were intact. Ten (26%) had already disrupted. A comparison of Kaplan-Meier survival curves indicated that the 62 third-generation gel implants manufactured by McGhan, Cox-Uphoff and Dow Corning were much more durable than 271 previously explanted second-generation gel implants. By contrast, the 38 third-generation Surgitek gel implants were less durable than the 271 second-generation implants.

The Brown Mite, Bryobia arborea Morgan and Anderson (Acarina: Tetranychidae), on Apple in Nova Scotia.: I. Influence of Intratree Distribution on the Selection of Sampling Units. II. Differences in Habits and Seasonal Trends in Orchards With Bivoltine and Trivoltine Populations. III. Distribution of Diapause Eggs. IV. Hatching of Diapause Eggs

1965 ◽  
Vol 97 (12) ◽  
pp. 1303-1318 ◽  
Author(s):  
H. J. Herbert
Keyword(s):  
Nova Scotia ◽  
First Generation ◽  
Second Generation ◽  
Central Area ◽  
Third Generation ◽  
Apple Trees ◽  
Seasonal Trends ◽  
Sample Unit ◽  
The Third ◽  
Selection Of

AbstractIn Nova Scotia one leaf cluster with an adjoining 1 inch of twig taken from the inside of each of 10 apple trees replicated four times is an adequate sample unit to measure the density of the brown mite.The brown mite has one generation with a partial second in some orchards and one with a partial second and partial third in others. The first generation adults in the bivoltine and trivoltine populations lay summer eggs on the leaves and twigs, and diapause eggs on tin twigs. The second generation adults in the bivoltine populations lay only diapause eggs; in the trivoltine populations they lay both summer and diapause eggs. The adults of the third generation lay only diapause eggs.The brown mite is found on both the leaves and woody parts of the tree. In orchards with bivoltine populations the proportion of mites on leaves reached a peak of 80% by mid-July, but thereafter gradually decreased to 10% by the end of August. However, in orchards with trivoltine populations the proportion of mites on leaves reached a peak of 80 to 90% by mid-July, remained constant until mid-August, and thereafter decreased to approximately 40% by the end of August.The number of diapause eggs laid by adults of each generation in both the bivoltine and trivoltine populations varies widely. The eggs are deposited on the trunk as well as on the branches, with the heaviest deposition in the central area of the tree. The diapause eggs laid by adults of the first generation are the last to hatch and those laid by the third generation are the first to hatch the following spring.The factors responsible for the differences in the number of generations and in the number of diapause eggs laid are unknown.

Distillery Configurations

2019 ◽  
pp. 47-64
Author(s):  
Karl Raitz
Keyword(s):  
Nineteenth Century ◽  
Labor Force ◽  
First Generation ◽  
Second Generation ◽  
High Capacity ◽  
Third Generation ◽  
Early Nineteenth Century ◽  
Railroad Tracks ◽  
Urban Rail ◽  
Capacity Output

Early-nineteenth-century farmers and millers were often craft distillers, mashing and fermenting grain meal in wooden barrels before distilling the liquid in small copper pot stills. Waterwheels powered the first-generation creek-side mills and distilleries. Wood fueled early steam engines; the use of coal required access to better transportation. Second-generation distilleries, operating from the 1830s to the 1880s, used traditional pot stills,although some adopted new column stills, perfected in Scotland, when they began to mechanize. Old still buildings were often modified to accommodate new machinery. Distillers stored whiskey-filled wooden barrels in stack warehouses to age. Industrialization required a larger labor force. By 1880, businesses in Louisville and other river cities were producing steam engines, boilers, and related equipment. Third-generation distilleries operated from the 1880s to 1920; their high-capacity output required more grain and fuel, mandating locations near railroad tracks or navigable rivers. Complementary industries such as cooperages, metal fabricators, slaughterhouses, and tanneries were attracted to urban, rail-side distilleries.

The Evolution of Breast Implants

2002 ◽  
Vol 10 (5) ◽  
pp. 223-236 ◽  
Author(s):  
Walter Peters
Keyword(s):  
United States ◽  
Breast Augmentation ◽  
Capsular Contracture ◽  
Surface Texturing ◽  
Breast Implants ◽  
Early Years ◽  
Present Review ◽  
Thick Wall ◽  
The Past ◽  
Silicone Gel

The present review traces the evolution of breast implants over the past 50 years. During the early years (from 1951 to 1962), a number of different sponges were used for breast augmentation. The first of these was Ivalon, a polyvinyl alcohol sponge. Other sponges were introduced subsequently, including Etheron (a poly-ether sponge popularized by Dr Paule Regnault in Montreal) and Polystan (fabric tapes that were wound into a ball). Subsequently, polyethylene strips enclosed in a fabric or polyethylene casing were also used for breast augmentation. All of these materials had similar outcomes. Although the initial results were encouraging, within one year of augmentation, breasts became very firm and lost over 25% of their volume. This was due to capsular contracture, a process that would lead to the collapse of the sponge and would continue to plague plastic surgeons and their patients for the next 50 years. In 1963, Cronin and Gerow introduced the silicone gel ‘natural feel’ implant, which revolutionized breast augmentation surgery. Approximately 10 companies have manufactured many types of silicone gel breast implants over the years. They obtained their raw materials for gels and shells from a similar number of other companies that entered and left the market at intervals. Many of the suppliers and manufactures changed their names and ownership over the years, and most of the companies no longer exist. No formal process of United States Food and Drug Administration premarket testing was in effect until 1988. There have been three generations of gel implants and a number of other lesser variations. First-generation implants (1963 to 1972) had a thick gel and a thick wall. They have generally remained intact over the years. Second-generation implants (1973 to the mid-1980s) had a thin gel and a thin wall. They have tended to disrupt over time. Third-generation implants (mid-1980s to 1992) had a thick wall and a thick gel. Except for those made by Surgitek, these implants remain intact. The breast implant business was competitive and companies introduced changes such as softer gels; barrier low-bleed shells; greater or lesser shell thickness; surface texturing; different sizes, contours and shapes; and multiple lumens in search of better aesthetics. Ultimately, more than 240 styles and 8300 models of silicone gel breast implants were manufactured in the United States alone. Inflatable breast implants were introduced in Toulons, France in 1965 (the Simaplast implant). There have been three main eras of inflatable implants: seamed, high-temperature vulcanized and room temperature vulcanized implants. In 1973, spontaneous deflation rates of 76% to 88% over three years were reported for many types of inflatable implants. Because of this, most plastic surgeons abandoned their use. From 1963 until the moratorium on gel implants (January 6, 1992), about 95% of all breast implants inserted were silicone gel filled. Only 5% were saline filled. Since the moratorium, this ratio has been reversed and 95% of all implants have been saline-filled, with only 5% being gel filled. Polyurethane-coated (PU) silicone gel implants were introduced in 1968. Over the next 20 years, they were shown to reduce the prevalence of capsular contracture to 2% to 3%. Other forms of surface texturing (Biocell, Siltex, multistructured implant) also appear to reduce capsular contracture with gel implants, but the reduction has been much less dramatic than that seen with PU implants. Contoured (anatomical) shaping appears to have advantages in some patients with gel implants. No such advantage has been seen for texturing or shaping with saline-filled implants. The story of gel implants has culminated in the largest class action lawsuit in medical history, with US$4.2 billion being awarded to women with silicone gel implants. During the past decade, there has been a tremendous amount of research on the reaction of a woman's body to gel implants. A plethora of studies have demonstrated that silicone gel implants are not associated with the development of any medical diseases. Silicone gel-filled implants have therefore been approved for use under Health Canada's Special Access Program. Silicone gel-filled implants may now be used in certain patients in whom they would provide advantages over saline implants. Silicone gel implants have not been approved for unrestricted general use. The evolution of breast implants occupies the past half century. It has been a stormy course, with many exciting advances and many bitter disappointments. The universe of breast implants is large and the variation among the implants is substantial. The purpose of the present review is to trace the evolution of breast implants over the past 50 years.

scholarly journals Development of a Divergent Route to Erythrina Alkaloids

Synlett ◽  
2020 ◽  
Vol 31 (04) ◽  
pp. 327-333 ◽  
Author(s):  
Jesper L. Kristensen ◽  
Sebastian Clementson ◽  
Mikkel Jessing ◽  
Paulo J. Vital
Keyword(s):  
Natural Products ◽  
Total Synthesis ◽  
19Th Century ◽  
First Generation ◽  
Second Generation ◽  
Enantioselective Synthesis ◽  
Third Generation ◽  
Synthetic Strategy ◽  
Erythrina Alkaloids ◽  
The 19Th Century

Erythrina alkaloids were identified at the end of the 19th century and today, more than 100 members of the erythrinane family have been isolated. They are characterized by a unique tetracyclic, α-tertiary spiroamine scaffold. Herein we detail our efforts towards the development of a divergent enantioselective synthesis of (+)-dihydro-β-erythroidine (DHβE) – one of the most prominent members of this intriguing family of natural products.1 Introduction2 Synthetic Strategy2.1 First Generation2.2 Second Generation2.3 Third Generation2.3.1 Radical Endgame2.3.2 Completion of the Total Synthesis3 Conclusion

Brominated β-Alkoxyvinyl Trihalomethyl Ketones as Promising Synthons in Heterocyclic Synthesis

Synthesis ◽  
2020 ◽  
Vol 52 (14) ◽  
pp. 2008-2016
Author(s):  
Mateus Mittersteiner ◽  
Nilo Zanatta ◽  
Helio G. Bonacorso ◽  
Marcos A. P. Martins
Keyword(s):  
First Generation ◽  
Second Generation ◽  
Building Blocks ◽  
Third Generation ◽  
Cycloaddition Reactions ◽  
Heterocyclic Synthesis

5-Bromo- and 5,5-dibromo-1,1,1-trihalo-4-methoxypent-3-en-2-ones (brominated enones) have proven to be attractive building blocks for the construction of heterocyclic and polyheterocyclic compounds bearing a trihalomethyl moiety through interesting cyclocondensation, alkylation, and cycloaddition reactions. This review compiles all of the reactions conducted with these brominated enones since they were first disclosed in 2001.1 Introduction2 Synthesis and Initial Applications3 Synthesis Using First-Generation Intermediates4 Synthesis Using Second-Generation Intermediates5 Synthesis Using Third-Generation Intermediates6 Conclusions

Evolution of a Chemical Strategy Toward the Synthesis of Unsymmetrically Oxidized Nuphar Alkaloids

Synlett ◽  
2019 ◽  
Vol 30 (14) ◽  
pp. 1632-1642
Author(s):  
Jacob J. Lacharity ◽  
Armen Zakarian
Keyword(s):  
Total Synthesis ◽  
First Generation ◽  
Second Generation ◽  
Third Generation ◽  
Successful Strategy ◽  
Synthesis Design ◽  
Sulfonium Ylide ◽  
Chemical Strategy

Here we describe the frustrations, joys, and unexpected turns experienced in our journey toward a successful strategy directed at the total synthesis of unsymmetrically oxidized Nuphar thioalkaloids. While many adjustments were made to our initial synthesis plan, our general approach to the construction of the central bis(spirothiolane) moiety remained unchanged. Specifically, each iteration of our synthesis design involved the formation of the thiaspirane motif through the stereodivergent coupling of a thietane with a metal carbenoid, followed by a Stevens-type rearrangement of the resulting sulfonium ylide.1 Introduction2 First-Generation Strategy3 Second-Generation Strategy4 Third-Generation Strategy5 Conclusion

scholarly journals Parameters of the seasonal cycle of Corythucha arcuata (Say, 1832) (Heteroptera: Tingidae) in the plains and foothills of the Northwestern Caucasus

2019 ◽  
pp. 101-128
Author(s):  
В.И. Щуров ◽  
А.С. Замотайлов
Keyword(s):  
First Generation ◽  
Second Generation ◽  
Egg Laying ◽  
Day Length ◽  
Fourth Generation ◽  
Third Generation ◽  
Degree Days ◽  
The Third ◽  
Female Immigrant ◽  
Northwestern Caucasus

Развитие первой генерации Corythucha arcuata в предгорьях и низкогорьях Северо-Западного Кавказа начинается в первых числах мая. При нижнем пороге пост-диапаузного развития имаго +11°С и при естественной длине дня ей требуется не менее 43 суток (аккумуляция 333-404 гр.-дн.). Гибель перезимовавших самок в этой зоне наблюдается к концу июня, совпадая с сокращением общей доли самок до 2-7%. В высокогорьях перезимовавшие имаго расселяются и в июне, доживая до июля на ивах и березах. Пик выхода имаго первого поколения приходится на конец июня. Массовая яйцекладка самками первого поколения (начало второго поколения) предваряется миграцией оплодотворенных самок на новые кормовые растения. Развитие преимагиальных стадий второго поколения (без смены кормовых растений) протекает с середины июня. Метаморфоз длится не менее 16-23 суток (361-430 гр.-дн.). Пик выхода имаго второго поколения в конце июля совпадает с массовым расселением, в котором всегда преобладают самки. Третье поколение развивается в августе. Метаморфоз занимает 19-28 суток (329-350 гр.-дн.). Пик выхода имаго третьего поколения приходится на первую декаду сентября. Его предваряет более ранний выход самцов, определяемый по их локальным и региональным миграциями с конца августа. Четвертое поколение является факультативным и развивается (без смены кормовых растений) с конца августа до третьей декады сентября. Развитие преимагиальных стадий этого поколения занимает не менее 26 суток (378 гр.-дн.). Последняя миграция клопов наблюдается в начале-середине октября. Самки третьего поколения первыми уходят в места зимовки в предгорьях и низкогорьях уже в середине сентября. Здесь, в дубовых лесах, зимуют имаго третьего и четвертого поколений обычно с преобладанием самок. В среднегорьях с ними могут зимовать особи-иммигранты второго поколения, но с преобладанием самцов, сохраняющимся с сентября. Development of the first generation of Corythucha arcuata in the climate of the foothills and lowlands of the Northwest Caucasus starts in the early May. With a natural day length and the threshold for post-diapause imago development of 11 °C, it requires 333-404 degree-days and at least 43 days. The death of the overwintered females in this zone is observed by the end of June, coinciding with the reduction of the total portion of females to 2-7%. In the highlands imagoes are dispersing in June as well, surviving until July on willows and birch trees. Peak of the first-generation imago outcome occurs at the end of June. Migration of fertilized females of the first generation to new forage plants is followed by mass egg laying (i.e. beginning of the second generation). During the formation of large nests in the foothills, the flight of bugs is observed even in treeless highlands. Development of the preadult stages of the second generation (without changing feed plants) takes place starting at mid-June. Metamorphosis requires 361-430 degree-days and takes at least 16-23 days. The peak of the emergence of the second generation imagoes at the end of July coincides with their dispersal, which is also dominated by females. The third generation develops in August. It requires 329-350 degree-days and takes 19-28 days. The peak of the emergence of the G3 imagoes falls on the first third of September. It is preceded by anearlier emergence of males, determined by their mass local and regional migrations since the end of August. The fourth generation is obligated and develops (without changing feed plants) from the end of August to the end of September. It requires at least 378 degree-days and takes at least 26 days. Late nymphs resulting from female immigrant of the third generation (on new trees) give imagoes only by mid-October. The last migration of bugs is observed in early to mid-October. Imagoes of the third and fourth generations with the predominance of females hibernate in the oak forests of the foothills and low-mountain. In the midlands they may be accompanied by the overwintering immigrants of the second generation, with the predominance of males, formed in September.

Outcomes of first, second, and third-generation anaplastic lymphoma kinase (ALK) inhibitors in non-small cell lung cancer brain metastases (NSCLCBM).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 2034-2034
Author(s):  
Vineeth Tatineni ◽  
Patrick Joseph O'Shea ◽  
Yasmeen Rauf ◽  
Xuefei Jia ◽  
Erin Sennett Murphy ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Brain Metastases ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
First Generation ◽  
Second Generation ◽  
Small Cell ◽  
Third Generation ◽  
Small Cell Lung ◽  
Alk Inhibitors

2034 Background: Non-small cell lung cancer (NSCLC) is the most common cause of brain metastases. ALK, which codes for tyrosine kinase receptors, is rearranged in 4-7% of NSCLC. First-generation ALK inhibitors have restricted efficacy due to poor blood-brain barrier (BBB) penetration and ALK-resistant tumor mutations. Second-generation ALK inhibitors have shown better BBB penetration, while third-generation ALK inhibitors were efficacious even against ALK-resistant mutations. In this retrospective study, we investigated the overall survival (OS) and progression-free survival (PFS) in NSCLCBM patients treated with first, second, and third-generation ALK inhibitors. Methods: NSCLCBM patients between 2010 and 2019 were evaluated. We analyzed data regarding molecular marker status, systemic therapies, and date of progression. OS was defined as the start date of systemic therapy to the date of last follow-up or death. The Cox proportional model was used to estimate OS and PFS. Results: A total of 90 patients had ALK gene rearrangement. 16 ALK positive patients received first-generation ALK inhibitor (crizotinib), with a median age of 59.2 years, 50% of the cohort being female and 83.3% being white. Another 17 patients received second-generation (alectinib, ceritinib, brigatinib) and third-generation ALK inhibitors (lorlatinib), with a combined median age of 52.2 years and a cohort of 52.6% females and 72.2% white patients. The 5-year OS rate was 49% (95% confidence interval (CI) = 24%, 71%) for first-generation ALK inhibitors and 76% (95% CI = 40%, 92%) for second and third-generation ALK inhibitors (p-value (p) = 0.019). The median PFS (mPFS) for patients who received first-generation ALK inhibitors was 45.3 months and for those who received second or third-generation ALK inhibitors was 180.1 months. The respective 5-year PFS rate was 43% (95% CI = 19%, 65%) and 72% (95% CI = 42%, 89%). Conclusions: Newer generations of targeted therapies in NSCLCBM have improved BBB penetration and effectiveness against resistant mutations. We determined that there was a significant 5-year OS benefit in patients who received second and third-generation ALK inhibitors compared to first-generation ALK inhibitors, and a respective trend towards significant PFS benefit in newer-generation ALK inhibitors when compared to first-generation. These results are encouraging, but the effect on intracranial lesion size and response rates should be examined in the future.[Table: see text]

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