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Mitchel S Berger

Publications and source records attributed to Mitchel S Berger.

At least 19 recordsLinked to original sources

Longitudinal profiling of IDH-mutant astrocytomas reveals acquired RAS-MAPK pathway mutations associated with inferior survival.

BACKGROUND: Isocitrate dehydrogenase (IDH)-mutant astrocytomas represent the most frequent primary intraparenchymal brain tumor in young adults, which typically arise as low-grade neoplasms that often progress and transform to higher grade despite current therapeutic approaches. However, the genetic alterations underlying high-grade transformation and disease progression of IDH-mutant astrocytomas remain inadequately defined. METHODS: Genomic profiling was performed on 205 IDH-mutant astrocytomas from 172 patients from both initial treatment-naive and recurrent post-treatment tumor specimens. Molecular findings were integrated with clinical outcomes and pathologic features to define the associations of novel genetic alterations in the RAS-MAPK signaling pathway. RESULTS: Likely oncogenic alterations within the RAS-MAPK mitogenic signaling pathway were identified in 13% of IDH-mutant astrocytomas, which involved the KRAS, NRAS, BRAF, NF1, SPRED1, and LZTR1 genes. These included focal amplifications and known activating mutations in oncogenic components (e.g. KRAS, BRAF), as well as deletions and truncating mutations in negative regulatory components (e.g. NF1, SPRED1). These RAS-MAPK pathway alterations were enriched in recurrent tumors and occurred nearly always in high-grade tumors, often co-occurring with CDKN2A homozygous deletion. Patients whose IDH-mutant astrocytomas harbored these oncogenic RAS-MAPK pathway alterations had inferior survival compared to those with RAS-MAPK wild-type tumors. CONCLUSIONS: These findings highlight novel genetic perturbations in the RAS-MAPK pathway as a likely mechanism contributing to the high-grade transformation and treatment resistance of IDH-mutant astrocytomas that may be a potential therapeutic target for affected patients and used for future risk stratification.

IDH1 mutation↗

Considerations in applying 3D PRESS H-1 brain MRSI with an eight-channel phased-array coil at 3 T.

The purpose of this study was to assess the benefits of a 3 T scanner and an eight-channel phased-array head coil for acquiring three-dimensional PRESS (Point REsolved Spectral Selection) proton (H-1) magnetic resonance spectroscopic imaging (MRSI) data from the brains of volunteers and patients with brain tumors relative to previous studies that used a 1.5 T scanner and a quadrature head coil. Issues that were of concern included differences in chemical shift artifacts, line broadening due to increased susceptibility at higher field strengths, changes in relaxation times and the increased complexity of the postprocessing software due to the need for combining signals from the multichannel data. Simulated and phantom spectra showed that very selective suppression pulses with a thickness of 40 mm and an overpress factor of at least 1.2 are needed to reduce chemical shift artifact and lipid contamination at higher field strengths. Spectral data from a phantom and those from six volunteers demonstrated that the signal-to-noise ratio (SNR) in the eight-channel coil was more than 50% higher than that in the quadrature head coil. For healthy volunteers and eight patients with brain tumors, the SNR at 3 T with the eight-channel coil was on average 1.5 times higher relative to the eight-channel coil at 1.5 T in voxels from normal-appearing brains. In combination with the effect of a higher field strength, the use of the eight-channel coil was able to provide an increase in the SNR of more than 2.33 times the corresponding acquisition at 1.5 T with a quadrature head coil. This is expected to be critical for clinical applications of MRSI in patients with brain tumors because it can be used to either decrease acquisition time or improve spatial resolution.

Adult↗

Intracranial microenvironment reveals independent opposing functions of host alphaVbeta3 expression on glioma growth and angiogenesis.

alphaVbeta3 integrins are overexpressed in the host-derived vasculature of glioblastoma multiform (GBM) and are believed to contribute to angiogenesis and tumor growth. To directly address the role of host alphaVbeta3 expression in GBM growth and behavior, we intracranially implanted integrin beta3-expressing GBM cells into beta3 wild type (WT) or beta3 knock out (KO) mice and monitored angiogenesis and growth. GBM in beta3 WT animals had a vessel density greater than that in beta3 KO animals, consistent with a pro-angiogenic, pro-tumorigenic view of host integrin function. GBM in beta3 WT animals, however, were no larger than those in beta3 KO animals, because GBM in beta3WT animals were infiltrated with a higher number of tumor necrosis factor alpha-secreting, apoptosis-inducing macrophages than the tumors in the corresponding beta3 KO animals. The tumor-suppressive effects of host beta3 expression could be reversed by macrophage depletion or by transplantation of bone marrow from beta3 KO animals into beta3 WT animals, both of which significantly increased tumor growth independently of tumor vessel density. Taken together, these results show that host alphaVbeta3 integrin expression has opposing actions in the intracranial setting, enhancing tumor vascularization and growth while independently enhancing macrophage-mediated tumor elimination. Appropriate management of these functions could lead to enhanced efficacy of anti-integrin based therapies for glioma.

Animals↗

mTOR-independent translational control of the extrinsic cell death pathway by RalA.

Oncogenic potential is associated with translational regulation, and the prevailing view is that oncogenes use mTOR-dependent pathways to up-regulate the synthesis of proteins critical for transformation. In this study, we show that RalA, a key mediator of Ras transformation, is also linked to the translational machinery. At least part of this linkage, however, is independent of mTOR and acts through RalBP1 to suppress cdc42-mediated activation of S6 kinase and the translation of the antiapoptotic protein FLIP(S). This action, rather than contributing to transformation, opens a latent tumor-suppressive mechanism that can be activated by tumor necrosis factor-related apoptosis-inducing ligand. These results show that the translational machinery is linked to tumor suppression as well as cell-proliferative pathways and that the reestablishment of cell death pathways by activation of the Ral oncogenic program provides a means for selective therapeutic targeting of Ral-driven malignancies.

ATP-Binding Cassette Transporters↗

Convection-enhanced delivery of Ls-TPT enables an effective, continuous, low-dose chemotherapy against malignant glioma xenograft model.

Treatment of malignant gliomas represents one of the most formidable challenges in oncology. The combination of surgery, radiation, and chemotherapy yields median survivals of less than one year. Here we demonstrate the use of a minimally invasive surgical technique, convection-enhanced delivery (CED), for local administration of a novel nanoparticle liposome containing topotecan. CED of this liposomal topotecan (Ls-TPT) resulted in extended brain tissue retention (t1/2 = 1.5 days), whereas free topotecan was rapidly cleared (t1/2 = 0.1 days) after CED. The favorable pharmacokinetic profile of extended topotecan release for about seven days, along with biodistribution featuring perivascular accumulation of the nanoparticles, provided, in addition to the known topoisomerase I inhibition, an effective antiangiogenic therapy. In the rat intracranial U87MG tumor model, vascular targeting of Ls-TPT with CED was associated with reductions in laminin expression and vascular density compared to free topotecan or control treatments. A single CED treatment on day 7 showed that free topotecan conferred no survival benefit versus control. However, Ls-TPT produced a significant (P = 0.0002) survival benefit, with six of seven complete cures. Larger U87MG tumors, where CED of Ls-TPT on day 12 resulted in one of six cures, indicated the necessity to cover the entire tumor with the infused therapeutic agent. CED of Ls-TPT was also efficacious in the intracranial U251MG tumor model (P = 0.0005 versus control). We conclude that the combination of a novel nanoparticle Ls-TPT and CED administration was very effective in treating experimental brain tumors.

Animals↗

Comparison of intratumoral bolus injection and convection-enhanced delivery of radiolabeled antitenascin monoclonal antibodies.

OBJECTIVES: Convection-enhanced delivery (CED) is a novel technique used to deliver agents to the brain parenchyma for treatment of neoplastic, infectious, and degenerative conditions. The purpose of this study was to determine if CED would provide a larger volume of distribution (Vd) of a radiolabeled monoclonal antibody (mAb) than a bolus injection. METHODS: Patients harboring a recurrent glioblastoma multiforme that reacted with the antitenascin mAb 81C6 during immunohistochemical analysis were randomized to receive an intratumoral injection of the human-murine chimeric mAb Ch81C6, which had been labeled with the 123I tracer. The mAb was administered by either a bolus injection or CED via a stereotactically placed catheter; between 48 and 72 hours later the mAb was again administered using the other technique. Injections of escalating doses of a 131I-labeled therapeutic mAb were then delivered using the technique shown to produce the largest Vd by single-photon emission computerized tomography. CONCLUSIONS: Convection-enhanced delivery has enormous potential for administering drugs to sites within the central nervous system. For the relatively small volumes injected in this study, however, CED did not provide a significant increase in the Vd when compared with the bolus injection. Nevertheless, a clear cross-over effect was seen, which was probably related to the temporal proximity of the two infusions.

Antibodies, Monoclonal↗

Safety of intraparenchymal convection-enhanced delivery of cintredekin besudotox in early-phase studies.

OBJECT: Convection-enhanced delivery (CED) is an increasingly used novel local/regional delivery method targeted directly to tissue. It relies on a continuous pressure gradient for distribution of therapeutic agents into the interstitial space, with administration of the infusate over a few days. Cintredekin besudotox (also known as IL13- PE38QQR) is a recombinant chimeric cytotoxin consisting of interleukin-13 and a truncated exotoxin produced by the Pseudomonas aeruginosa bacterium, which targets malignant glioma cells. METHODS: Cintredekin besudotox was administered via intraparenchymal CED after resection of supratentorial recurrent malignant glioma. The safety and toxicity profile was reviewed for 53 patients in whom infusion catheters had been placed; 51 of them received CED of the study drug. Adverse events were categorized based on time of onset in relation to CED, and the causal relationship with catheter placement or delivery of cintredekin besudotox. Catheters were placed in 53 patients, although only 51 of them received cintredekin besudotox. Most adverse events related to catheter placement or the study drug originated from the central nervous system. Three symptomatic windows were defined: the first one was between surgical procedure and CED; the second was during CED and up to 1 week after its completion; and the third window was 2 to 10 weeks after treatment. Those windows generally reflected adverse events related to surgical procedures, mass effect from infusate, and drug effect on tumor-infiltrated and normal brain parenchyma, respectively. CONCLUSIONS: The symptomatic windows identified in this study apply to any CED clinical trials, particularly those in which chimeric cytotoxins are used, and will help to determine the most likely underlying pathophysiological process causing symptoms. This information, in turn, will help to prevent adverse events or minimize their severity. Those events also have implications for dose escalation and outcome measures.

Adult↗

Novel nanoliposomal CPT-11 infused by convection-enhanced delivery in intracranial tumors: pharmacology and efficacy.

We hypothesized that combining convection-enhanced delivery (CED) with a novel, highly stable nanoparticle/liposome containing CPT-11 (nanoliposomal CPT-11) would provide a dual drug delivery strategy for brain tumor treatment. Following CED in rat brains, tissue retention of nanoliposomal CPT-11 was greatly prolonged, with >20% injected dose remaining at 12 days for all doses. Tissue residence was dose dependent, with doses of 60 microg (3 mg/mL), 0.8 mg (40 mg/mL), and 1.6 mg (80 mg/mL) resulting in tissue half-life (t(1/2)) of 6.7, 10.7, and 19.7 days, respectively. In contrast, CED of free CPT-11 resulted in rapid drug clearance (tissue t(1/2) = 0.3 day). At equivalent CED doses, nanoliposomal CPT-11 increased area under the time-concentration curve by 25-fold and tissue t(1/2) by 22-fold over free CPT-11; CED in intracranial U87 glioma xenografts showed even longer tumor retention (tissue t(1/2) = 43 days). Plasma levels were undetectable following CED of nanoliposomal CPT-11. Importantly, prolonged exposure to nanoliposomal CPT-11 resulted in no measurable central nervous system (CNS) toxicity at any dose tested (0.06-1.6 mg/rat), whereas CED of free CPT-11 induced severe CNS toxicity at 0.4 mg/rat. In the intracranial U87 glioma xenograft model, a single CED infusion of nanoliposomal CPT-11 at 1.6 mg resulted in significantly improved median survival (>100 days) compared with CED of control liposomes (19.5 days; P = 4.9 x 10(-5)) or free drug (28.5 days; P = 0.011). We conclude that CED of nanoliposomal CPT-11 greatly prolonged tissue residence while also substantially reducing toxicity, resulting in a highly effective treatment strategy in preclinical brain tumor models.

Animals↗

The role of up-front radiation therapy for incompletely resected pediatric WHO grade II low-grade gliomas.

The purpose of this study was to assess the impact of early radiation therapy and extent of surgical resection on progression-free survival (PFS) and overall survival (OS) in children with WHO grade II low-grade gliomas (LGGs). We conducted a historical cohort study of 90 patients, ages 21 or younger, diagnosed with WHO grade II LGGs between 1970 and 1995. Median follow-up for surviving patients was 9.4 years (range, 0.5-22.6 years). Tests for variables correlating with OS and PFS were conducted by using log-rank tests and Cox proportional hazards models. Eleven patients underwent gross total resections (GTRs), 43 had subtotal resections, and 34 underwent biopsy only at diagnosis. Two patients underwent biopsy at time of recurrence. Of the 90 patients, 52 received radiation as part of their initial therapy following diagnosis (early-RT group). The overall five-year PFS and OS rates +/- SE were 56% +/- 5% and 90% +/- 3%, respectively. Ten-year PFS and OS rates were 42% +/- 6% and 81% +/- 5%, respectively. For patients older than three years and without GTRs, administration of early radiation did not appear to influence PFS or OS (P = 0.98 and P = 0.40, respectively; log-rank test). This was confirmed by multivariate analyses (P = 0.95 and P = 0.33 for PFS and OS, respectively). Of the 11 patients with GTRs, disease progressed in only two, and all were alive with no evidence of disease at last follow-up. Patients who underwent GTRs had significantly longer PFS (P = 0.02), but did not have significantly improved OS. Excellent long-term survival rates were achieved for children with WHO grade II LGGs. We were unable to demonstrate a benefit for administering radiation as part of initial treatment. An outcome benefit was seen with greater extent of resection.

Adolescent↗

Tissue affinity of the infusate affects the distribution volume during convection-enhanced delivery into rodent brains: implications for local drug delivery.

Convection-enhanced delivery (CED) is a recently developed technique for local delivery of agents to a large volume of tissue in the central nervous system (CNS). We have previously reported that this technique can be applied to CNS delivery of nanoparticles including viruses and liposomes. In this paper, we describe the impact of key physical and chemical properties of infused molecules on the extent of CED-mediated delivery. For simple infusates, CED distribution was significantly increased if the infusate was more hydrophilic or had less tissue affinity. Encapsulation of tissue-affinitive molecules by neutral liposomes significantly increased their tissue distribution. The poorer brain distribution observed with cationic liposomes, due to their greater tissue affinity, was completely overcome by PEGylation, which provides steric stabilization and reduced surface charge. Finally, liposomal encapsulation of doxorubicin reduced its tissue affinity and substantially increased its distribution within brain tumor tissue. Taken together, the physical and chemical properties of drugs, small molecules and macromolecular carriers determine the tissue affinity of the infusate and strongly affect the distribution of locally applied agents. Thus, an increased and more predictable tissue distribution can be achieved by reducing the tissue affinity of the infusate using appropriately engineered liposomes or other nanoparticles.

Animals↗

Feasibility of dynamic susceptibility contrast perfusion MR imaging at 3T using a standard quadrature head coil and eight-channel phased-array coil with and without SENSE reconstruction.

PURPOSE: To investigate changes in image and dynamic signal-to-noise ratios (SNRs) of the DeltaR2* curve, as well as magnetic susceptibility-induced artifacts between a standard quadrature head coil and an eight-channel phased-array coil with and without sensitivity-encoding (SENSE) at 3T, compared to the current clinical standard head coil acquisition at 1.5T. MATERIALS AND METHODS: Dynamic susceptibility contrast (DSC) perfusion MRI was performed on 80 brain tumor patients using a gradient-echo, echo-planar imaging (EPI) sequence. Image and dynamic SNR were compared between 1.5T and 3T field strengths, a quadrature and eight-channel phased-array coil, and a conventional vs. partially parallel EPI acquisition with SENSE reconstruction. The amount of geometric distortion and signal dropout was quantified and compared between conventional and SENSE EPI acquisitions within the same exam at 3T. RESULTS: An initial 2.6-fold elevation in dynamic SNR was observed in normal-appearing white matter when doubling the field strength (P < 0.001), with an additional 1.7-fold increase found when employing an eight-channel phased-array coil (P < 0.002). Compared to the standard 3T eight-channel coil acquisition, the implementation of SENSE reduced the number of voxels experiencing large anterior shifts in the phase-encode direction, lowered the volume of signal dropout by 2.0-11.5%, and allowed a 1.4-fold increase in slice coverage, while only decreasing the dynamic SNR by 22%. CONCLUSION: SENSE EPI at 3T yielded a significant improvement in dynamic SNR over the 1.5T acquisitions. A significant reduction in magnetic susceptibility-induced artifacts was achieved with SENSE EPI compared to the standard EPI eight-channel coil acquisition at 3T.

Adult↗

Unaliasing lipid contamination for MR spectroscopic imaging of gliomas at 3T using sensitivity encoding (SENSE).

3D magnetic resonance spectroscopic imaging (MRSI) has been successfully employed to extract information about brain tumor metabolism, such as cell membrane breakdown, cellular energetics, and neuronal integrity, through its ability to differentiate signals coming from choline (Cho), creatine (Cr), and N-acetyl aspartate (NAA) molecules. The additional presence of lipids within subregions of the tumor may indicate cellular membrane breakdown due to cell death. Another potential source of lipids is subcutaneous fat, which may be excited with point-resolved spectroscopy (PRESS) volume selection and aliased into the spectral field of view (FOV) due to the chemical shift artifact and the low bandwidth of the selection pulses. The purpose of our study was to employ a postprocessing method for unaliasing lipid resonances originating from in-slice subcutaneous lipids from the 3D MRSI of gliomas at 3T, using an eight-channel phased-array coil and sensitivity encoding (SENSE).

Algorithms↗

Definition and diagnostic implications of gemistocytic astrocytomas: a pathological perspective.

Gemistocytic astrocytoma still continues to be enigmatic; both in terms of definition and prognostic implications. The major issue of contention has been the clinical relevance of this pathological entity. The currently accepted definition of gemistocytic astrocytoma requires 20% or more gemistocytes, and considers the neoplasm as a diffuse astrocytoma, which is a WHO grade II tumor. Some suggest that gemistocytic morphology should be considered as evidence of a higher grade astrocytoma. However, there is no consensus on the percentage of gemistocytes associated with a worse prognosis than otherwise expected. Given the reported cases and series, it is not clear that this morphology portends a more aggressive biology when all else is equal. There is still a need for studies with sufficient numbers of well-matched gemistocytic and non-gemistocytic astrocytic neoplasms to decide whether upgrading a tumor with 'significant' number of gemistocytes is justifiable. This article presents a critical review of the existing studies and a brief mention of our experience from a pathological perspective.

Astrocytoma↗

Evaluation of epidemiologic evidence for primary adult brain tumor risk factors using evidence-based medicine.

We evaluate genetic, behavioral, developmental and experiential risk factors for primary adult brain tumors (primarily, astrocytoma and meningioma) using a systematic set of principles adapted from evidence-based medicine standards. In addition to ionizing radiation, rare mutations in highly penetrant genes associated with certain diseases/syndromes, and epilepsy and seizures (which probably result from, rather than cause, adult brain tumors), only the unexplained observation of familial aggregation of astrocytoma has been consistently shown. There is promising renewed interest in associations between infections, allergic conditions and adult brain tumor risk. Our knowledge of the causes of adult brain tumors is limited and should be expanded by results from large, well-designed studies of novel potential risk factors and potential interactions between known and suspected risk factors.

Astrocytoma↗

Extended bifrontal craniotomy for midline anterior fossa meningiomas: minimization of retraction-related edema and surgical outcomes.

OBJECTIVE: Meningiomas of the anterior cranial base can be approached with a variety of techniques. The extended bifrontal approach is often thought to be associated with increased morbidity because of the need for extensive removal of the bone and longer surgical times. The authors have attempted to quantitate retraction-related edema occurring after surgery to determine whether the extra bone removal limits retraction and reduces the chance of brain injury. METHODS: Charts were reviewed for patients who underwent extended bifrontal craniotomies performed for meningiomas at the University of California, San Francisco, between 1997 and 2005. Magnetic resonance imaging scans obtained before and after surgery were reviewed for brain edema as indicated by fluid-attenuated inversion recovery/T2 abnormality and grouped into four categories: A, no edema; B, edema restricted to the gyrus rectus; C, edema beyond the gyrus rectus; and D, extensive bifrontal edema. RESULTS: Forty-five patients were identified. Fifty-four percent of patients had tumors with a diameter of more than 4 cm. Simpson Grade 2 or 3 resection was achieved in 82% of patients, and the average operative time was 12.3 hours. Vision outcome was favorable in 74% of patients. Extent of fluid-attenuated inversion recovery abnormality remained unchanged in 87.5%, with 91% of patients in categories A or B edema remaining in those categories after surgery. There were no infections and there were two cerebrospinal fluid leaks. CONCLUSION: The extended bifrontal approach is a safe surgical procedure with limited morbidity that the authors think: 1) prevents secondary brain injury from excessive retraction; 2) offers great flexibility of view for the surgeon; and 3) should be considered the preferred approach compared with the standard bifrontal craniotomy for large tumors of the anterior cranial base.

Adult↗

Volumetric extent of resection and residual contrast enhancement on initial surgery as predictors of outcome in adult patients with hemispheric anaplastic astrocytoma.

OBJECT: To investigate the prognostic significance of the volumetrically assessed extent of resection on time to tumor progression (TTP), overall survival (OS), and tumor recurrence patterns, the authors retrospectively analyzed preoperative and postoperative tumor volumes in 102 adult patients from the time of the initial resection of a hemispheric anaplastic astrocytoma (AA). METHODS: The quantification of tumor volumes was based on a previously described method involving computerized analysis of magnetic resonance (MR) images. Analysis of contrast-enhancing tumor volumes on T1-weighted MR images was conducted for 67 patients who had contrast-enhancing tumors. Measurements of T2 hyperintensity were obtained for all 102 patients in the study. The presence or absence of preresection enhancement, actual volume of this enhancement, and the percentage of preoperative enhancement as it relates to the total T2 tumor volume did not have a statistically significant relationship to TTP or OS. In addition to age, the volume of residual disease measured on T2-weighted MR images was the most significant predictor of TTP (p < 0.001), and residual contrast-enhancing tumor volume was the most significant predictor of OS (p = 0.003) on multivariate analysis. In contrast to low-grade gliomas, there was no statistically significant relationship between the extent of resection and histological characteristics at the time of recurrence, that is, tumor Grade III compared with Grade IV. CONCLUSIONS: Data from this retrospective analysis of a histologically uniform group of hemispheric AAs treated in the MR imaging era suggest that residual tumor volumes, as documented on postoperative imaging studies, may be a prognostic factor for TTP and OS for this patient population.

Adult↗

Motor field sensitivity for preoperative localization of motor cortex.

OBJECT: In this study the role of magnetic source imaging for preoperative motor mapping was evaluated by using a single-dipole localization method to analyze motor field data in 41 patients. METHODS: Data from affected and unaffected hemispheres were collected in patients performing voluntary finger flexion movements. Somatosensory evoked field (SSEF) data were also obtained using tactile stimulation. Dipole localization using motor field (MF) data was successful in only 49% of patients, whereas localization with movement-evoked field (MEF) data was successful in 66% of patients. When the spatial distribution of MF and MEF dipoles in relation to SSEF dipoles was analyzed, the motor dipoles were not spatially distinct from somatosensory dipoles. CONCLUSIONS: The findings in this study suggest that single-dipole localization for the analysis of motor data is not sufficiently sensitive and is nonspecific, and thus not clinically useful.

Brain Mapping↗

Biomarkers to predict response to epidermal growth factor receptor inhibitors.

Epidermal growth factor receptors (EGFRs) are amplified and overexpressed in many different human cancers, a phenomenon generally associated with poor prognosis. Inhibitors of the tyrosine kinase activity associated with this receptor have been approved for the treatment of chemotherapy-refractory nonsmall cell lung cancer, and are in clinical trials for additional tumor types. While these inhibitors, gefitinib and erlotinib, display limited response rates when assessed in cohorts that include all patients, there are subgroups, defined by patient and tumor characteristics, that preferentially respond to these agents. We recently performed an analysis of tumors obtained from a Phase I trial of erlotinib in patients with glioblastoma multiforme (GBM), the most common malignant brain tumor in adults. We showed that patients whose tumors exhibited overexpression and amplification of EGFR responded better than patients who had normal levels of this gene and protein. We also demonstrated that the phosphorylation state of PKB/Akt was an important determinant for response, with low phospho-PKB/Akt levels predicting good response to erlotinib. We discuss these findings in the context of recent molecular analyses of the placebo-controlled Phase III trials that led to approval of EGFR inhibitors. These data underscore the importance of placebo-controlled trials to distinguish between prognostic indicators of disease progression more generally and predictive markers of response to therapy. Ultimately the goal of these studies is to allow selection of patients who will preferentially respond to EGFR inhibitors.

Biomarkers↗