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Purpose: Granulocyte/macrophage colony-stimulating factor (GM-CSF) administered locally together with vaccines can augment T-cell responses in animal models. Human experience has been limited to small and uncontrolled trials. Thus, a multicenter randomized phase II trial was done to determine whether local administration of GM-CSF augments immunogenicity of a multipeptide vaccine. It also assessed immunogenicity of administration in one versus two vaccine sites.Experimental Design: One hundred twenty-one eligible patients with resected stage IIB to IV melanoma were vaccinated with 12 MHC class Irestricted melanoma peptides to stimulate CD8+ T cells plus a HLA-DRrestricted tetanus helper peptide to stimulate CD4+ T cells, emulsified in incomplete Freund's adjuvant, with or without 110 g GM-CSF. Among 119 evaluable patients, T-cell responses were assessed by IFN- ELIspot assay and tetramer analysis. Clinical outcomes were recorded.Results: CD8+ T-cell response rates to the 12 MHC class Irestricted melanoma peptides (by day 50) with or without GM-CSF were 34 and 73, respectively (P < 0.001), by direct ELIspot assay. Tetramer analyses corroborated the functional data. CD4+ T-cell responses to tetanus helper peptide were higher without GM-CSF (95 versus 77; P = 0.005). There was no significant difference by number of vaccine sites. Three-year overall and disease-free survival estimates (95 confidence interval) were 76 (67-83) and 52 (43-61), respectively, with too few events to assess differences by study group.Conclusions: High immune response rates for this multipeptide vaccine were achieved, but CD8+ and CD4+ T-cell responses were lower when administered with GM-CSF. These data challenge the value of local GM-CSF as a vaccine adjuvant in humans. (Clin Cancer Res 2009;15(22):703644)

CCR Translation for the Article from Effect of Granulocyte/Macrophage Colony-Stimulating Factor on Circulating CD8+ and CD4+ T-Cell Responses to a Multipeptide Melanoma Vaccine: Outcome of a Multicenter Randomized Trial

Supplementary Data from Effect of Granulocyte/Macrophage Colony-Stimulating Factor on Circulating CD8+ and CD4+ T-Cell Responses to a Multipeptide Melanoma Vaccine: Outcome of a Multicenter Randomized Trial

Introduction: Obesity is associated with a 41% increase in all-cause mortality in breast cancer survivors. The majority of patients treated for breast cancer at our center are obese and most patients are racial and ethnic minority women living in low-income neighborhoods. Numerous barriers exist for weight management and physical activity interventions in this patient population. We aimed to assess the feasibility of a lifestyle intervention in 30 obese breast cancer survivors using shared medical appointments and community partnerships. Methods: 30 patients with stage I-III breast cancer with a BMI ≥30 kg/m2 treated in the preceding 5 years were enrolled through medical oncology and breast surgery clinics. All participants were given a Fitbit® to monitor physical activity and a $25 grocery gift card for a shopping trip with a nutritionist. Participants were expected to attend at least 10 group shared medical appointments (SMA) offered weekly on-site. SMA included nutrition education, cooking instruction, exercise classes or survivorship lectures. We collected participant feedback on SMA. Initial study end points were feasibility of intervention delivery measured by number of SMA appointments and physical activity (steps) measured by Fitbit®. The study was divided in three phases. Phase I/II: patients were required to have baseline evaluations, attend 10 SMA, share Fitbit® information, and complete validated eating and health questionnaires (REAP-S and SF-36, respectively) at scheduled time intervals. In phase III, we provided participants with a binder with information on low-cost fitness and nutrition options in patient’s neighborhoods and awarded prizes for high-performing participants. Results: We enrolled 30/30 participants in less than 6 months from opening; 80% were African-American. Three enrolled subjects did not complete more than one SMA. Participants attended an average of 10.2 SMA; attendance ranged from 5-10 participants per session. 63% (n=19) of participants attended the required 10 or more of the required SMA sessions (average compliance with clinic appointments is 50-60%). Participants had an average of -0.18 kg weight loss; 43% (n=13) lost weight and 40% (n=12) gained weight during the intervention (5 participants lost to follow-up or did not have weight changes during intervention). The range of weight loss was 0.1 to 7 kg and weight gain 0.2 to 6.2 kg. Twenty-four participants had consistent Fitbit® steps recorded; 19 increased their average of daily steps and 7 decreased from baseline, however, the steps varied significantly week to week. At baseline, average daily steps was 3,977 (range 200 to 18,432; SD = 4,236 steps) and 5,526 (range 728 to 14,006; SD = 2437 steps) post- intervention. The number of participants who increased steps (n=19) was significantly greater than the number of participants who decreased steps (n=7; p=0.014). The total cost of the intervention was $150 per patient. Challenges to study implementation included collection of Fitbit® data at consistent intervals and the available times for offering SMA; these times precluded enrollment and compliance for patients who work during the day. Conclusions: Our pilot study of a low-cost lifestyle intervention program appears to be feasible and beneficial for obese patients in a largely underserved community. SMA contributed to compliance and had positive feedback; patients expressed high levels of interest and engagement in the intervention. After the intervention participants were motivated to continue with lifestyle modifications and formed a Facebook® page to maintain connections. In the future, the goal is to incorporate this program as part of our survivorship care and expand it to other malignancies and potentially to other sites. Citation Format: Ilana Schlam, Princess Alintah, Christopher Gallagher, Marc Boisvert, Ami Chitalia, Shruti Tiwari, Patrick Martone, Chiranjeev Dash, Kristi Graves, Asma Dilawari. A lifestyle intervention program for obese breast cancer survivors using shared appointments, technology, and community partners in an underserved area [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-13-07.

Introduction: Racial disparities in breast cancer outcomes are well documented with age-adjusted mortality among African American (AA) women 40% higher than Caucasian women. Some studies have demonstrated poor response to neoadjuvant chemotherapy in AA with triple negative breast cancer but data regarding pathologic complete response rate (pCR) in HER2 positive disease are lacking. TRYPHAENA trial demonstrated a high pCR rate after treatment with dual HER2 blockage along with chemotherapy. Due to underrepresentation of African Americans and minorities in the trials leading to the approval of dual HER2 blockage (Gianni et al; Lancet Oncology;13: 25-32) in early stage breast cancer, data is lacking on the efficacy and tolerability of this treatment in this subgroup of patients. Methods: After IRB approval, pharmacy records were utilized to identify patients treated with dual HER2 blockade in neoadjuvant setting at our institution. Individual patient charts were reviewed to identify AA patients and other ethnic minorities. We also obtained details of the patient age, clinical stage, pathological stage, ER/PR status, treatment received, side effects leading to dose reductions if any. pCR was defined as absence of invasive or noninvasive cancer in the breast and lymph nodes (ypT0N0). Results:50 patients with a median age of 53 years met our inclusion criteria. 86% patients self-reported as AA and 14% were other minorities as recorded in EMR. 90% patients were treated with Taxotere, Carboplatin, Trastuzumab and Pertuzumab (TCHP) and 10% received Adriamycin, Cyclophosphamide, Paclitaxel, Trastuzumab and Pertuzumab (AC-THP) chemotherapy. Clinical staging was: Stage I- 4 %; Stage II- 84 %, and Stage III- 12 %. 46% of patients had hormone receptor (HR) positive tumors and 54% patients were HR negative. 30% (15/50) of patients required dose reduction or omission for diarrhea, neuropathy, or cytopenia. 18%(9/50) patients had doses omitted. The overall observed pCR rate (ypT0N0) was 42%(21/50). As expected, the pCR rate was higher in patients with HR negative/HER2 positive breast cancer compared to HR positive/HER2 positive breast cancer. 44% (12/27) vs. 39% (9/23), respectively.Conclusion: Dual HER2 blockade was associated with a lower pCR rate (42%) in AA and other minorities compared to rate of 52% as reported by TRYPHAENA trial (n=77). The treatment was well tolerated but higher percent of patients required a dose reduction or omission (Tiwari et al; Breast Cancer Res Treat; 158:189-193).The most common side effects were diarrhea, neuropathy and cytopenias. Further prospective studies are needed to elucidate the role of biologic differences in chemosensitivity and balancing the variables of increased number of dose reductions and effect of socioeconomic differences in an underserved minority population. Citation Format: Shruti R Tiwari, Prasun Mishra, Asma Dilawari, Christopher M Gallagher, Ami Chitalia, Patricia Wehner, Marc E Boisvert. Lower pathologic complete response rate with dual-HER2 blockage and chemotherapy in African Americans and ethnic minorities [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-10-10.

Breast cancer in African-American females (AAF) has a less favorable outcome than that in Caucasians. More information is needed regarding its biology. We evaluated gene expression in tumors from AAF presenting with early stage or locally advanced breast cancer using MammaPrint(®), BluePrint (®) (molecular subtype) and TargetPrint (®) [estrogen receptor (ER), progesterone receptor, and Human Epidermal Growth Factor Receptor 2 (HER2) mRNA levels]. Genomic information was correlated with clinical and pathologic characteristics and Oncotype DX(®) Recurrence Score(®) (RS). One hundred Patients were enrolled, 1 not evaluable by BluePrint. The median age was 60 years (range 22-98), and eighty-four (84 %) patients had stage I or II disease. High Risk MammaPrint was present in 66 % of patients and in 52 % of patients with stage I disease. High Risk MammaPrint was associated with young age (p = 0.02), high grade (p 0.0001), HER2 expression (p = 0.016), and triple-negative phenotype (p 0.001). Sixty-four tumors (65 %) were Luminal type (47 % of these were classified as High Risk), 26 (26 %) were Basal type, and 9 (9 %) HER2 type. Twenty-two cancers were triple negative (TN) by IHC and 19 (90 %) Basal type. Among the 15 tumors HER2 positive by IHC/FISH, 8 (53 %) were HER2 type by BluePrint. Eleven tumors with ER expression of 1-9 % were ER negative by TargetPrint and none of these was Luminal type. None of the seven tumors HER2 positive by IHC/FISH but negative by TargetPrint was HER type. RS results were available in 29 patients: two had High Risk both by RS and MammaPrint; eight had intermediate RS, with four High Risk by MammaPrint; 19 had a low RS, with eight High Risk by MammaPrint. AAF with stage I to III breast cancer often present with High Risk disease. Molecular heterogeneity is present within TN, HER2-positive, and ER-positive breast cancer. RS and MammaPrint offer different prognostic information.

Practice guidelines incorporate genomic tumor profiling, using results such as the Oncotype DX Recurrence Score (RS), to refine recurrence risk estimates for the large proportion of breast cancer patients with early-stage, estrogen receptor-positive disease. We sought to understand the impact of receiving genomic recurrence risk estimates on breast cancer patients' well-being and the impact of these patient-reported outcomes on receipt of adjuvant chemotherapy. Participants were 193 women (mean age 57) newly diagnosed with early-stage breast cancer. Women were interviewed before and 2-3 weeks after receiving the RS result between 2011 and 2015. We assessed subsequent receipt of chemotherapy from chart review. After receiving their RS, perceived pros (t = 4.27, P < .001) and cons (t = 8.54, P < .001) of chemotherapy increased from pre-test to post-test, while perceived risk of breast cancer recurrence decreased (t = 2.90, P = .004). Women with high RS tumors were more likely to receive chemotherapy than women with low RS tumors (88 vs. 5 %, OR 0.01, 0.00-0.02, P < .001). Higher distress (OR 2.19, 95 % CI 1.05-4.57, P < .05) and lower perceived cons of chemotherapy (OR 0.50, 95 % CI 0.26-0.97, P < .05) also predicted receipt of chemotherapy. Distressed patients who saw few downsides of chemotherapy received this treatment. Clinicians should consider these factors when discussing chemotherapy with breast cancer patients.

Delays to surgical breast cancer treatment of 90 days or more may be associated with greater stage migration. We investigated racial disparities in time to receiving first surgical treatment in breast cancer patients. Insured black (56 %) and white (44 %) women with primary breast cancer completed telephone interviews regarding psychosocial (e.g., self-efficacy) and health care factors (e.g., communication). Clinical data were extracted from medical charts. Time to surgery was measured as the days between diagnosis and definitive surgical treatment. We also examined delays of more than 90 days. Unadjusted hazard ratios (HRs) examined univariate relationships between delay outcomes and covariates. Cox proportional hazard models were used for multivariate analyses. Mean time to surgery was higher in blacks (mean 47 days) than whites (mean 33 days; p = .001). Black women were less likely to receive therapy before 90 days compared to white women after adjustment for covariates (HR .58; 95 % confidence interval .44, .78). Health care process factors were nonsignificant in multivariate models. Women with shorter delay reported Internet use (vs. not) and underwent breast-conserving surgery (vs. mastectomy) (p

Chemotherapy improves breast cancer survival but is underused more often in black than in white women. We examined associations between patient-physician relationships and chemotherapy initiation and timeliness of initiation among black and white patients. Women with primary invasive, non-metastatic breast cancer were recruited via hospitals (in Washington, DC and Detroit) and community outreach between July 2006 and April 2011. Data were collected via telephone interviews and medical records. Logistic regression models evaluated associations between chemotherapy initiation and independent variables. Since there were race interactions, analyses were race-stratified. Factors associated with time from surgery to chemotherapy initiation and delay of ≥90 days were evaluated with linear and logistic regressions, respectively. Among eligible women, 82.8 % were interviewed and 359 (90.9 %) of those had complete data. The odds of initiating chemotherapy were 3.26 times (95 % CI: 1.51, 7.06) higher among black women reporting greater communication with physicians (vs. lesser), after considering covariates. In contrast, the odds of starting chemotherapy were lower for white women reporting greater communication (vs. lesser) (adjusted OR 0.22, 95 % CI: 0.07, 0.73). The opposing direction of associations was also seen among the sub-set of black and white women with definitive clinical indications for chemotherapy. Among those initiating treatment, black women had longer mean time to the start of chemotherapy than whites (71.8 vs. 55.0 days, p = 0.005), but race was not significant after considering trust in oncologists, where initiation time decreased as trust increased, controlling for covariates. Black women were also more likely to delay ≥90 days than whites (27 vs. 8.3 %; p = 0.024), but this was not significant after considering religiosity. The patient-physician dyad and sociocultural factors may represent leverage points to improve chemotherapy patterns in black women.

Single-dose intraoperative radiotherapy (IORT) is an emerging treatment for women with early stage breast cancer. The objective of this study was to define the frequency of IORT use, patient selection, and outcomes of patients treated in North America.A multi-institutional retrospective registry was created, and 19 institutions using low-kilovoltage IORT for the treatment of breast cancer entered data on patients treated at their institution before July 31, 2013. Patient selection, IORT treatment details, complications, and recurrences were analyzed.From 2007 to July 31, 2013, a total of 935 women were identified and treated with lumpectomy and IORT. A total of 822 patients had at least 6 months' follow-up documented and were included in the analysis. The number of IORT cases performed increased significantly over time (p 0.001). The median patient age was 66.8 years. Most patients had disease that was2 cm in size (90 %) and was estrogen positive (91 %); most patients had invasive ductal cancer (68 %). Of those who had a sentinel lymph node procedure performed, 89 % had negative sentinel lymph nodes. The types of IORT performed were primary IORT in 79 %, secondary IORT in 7 %, or planned boost in 14 %. Complications were low. At a median follow-up of 23.3 months, crude in-breast recurrence was 2.3 % for all patients treated.IORT use for the treatment of breast cancer is significantly increasing in North America, and physicians are selecting low-risk patients for this treatment option. Low complication and local recurrence rates support IORT as a treatment option for selected women with early stage breast cancer.

Placental-specific protein 1 (PLAC1) is an X-linked trophoblast gene that is re-expressed in several malignancies, including breast cancer, and is therefore a potential biomarker to follow disease onset and progression. Sera from 117 preoperative/pretreatment breast cancer patients and 51 control subjects, including those with fibrocystic disease, were analyzed for the presence of PLAC1 protein as well as its expression by IHC in tumor biopsies in a subset of subjects. Serum PLAC1 levels exceeded the mean plus one standard deviation (mean+SD) of the level in control subjects in 67% of subjects with ductal carcinoma in situ (DCIS), 67% with HER2+ tumors, 73% with triple-negative cancer and 73% with ER+/PR+ tumors. Greater sensitivity was achieved using the mean+2 SD of control PLAC1 serum values, where the false positive rate was 3% and was exceeded by 38%, 40%, 60% and 43% of subjects with DCIS, HER2+, TNBC and ER+/PR+/HER2- tumors. PLAC1 was detected in 97% of tumor biopsies, but did not correlate quantitatively with serum levels. There was no significant correlation of serum PLAC1 levels with race, age at diagnosis, body mass index (BMI) or the presence of metastatic disease. It remains to be determined whether PLAC1 serum levels can serve as a diagnostic biomarker for the presence or recurrence of disease post-surgery and/or therapy.

Purpose: Granulocyte/macrophage colony-stimulating factor (GM-CSF) administered locally together with vaccines can augment T-cell responses in animal models. Human experience has been limited to small and uncontrolled trials. Thus, a multicenter randomized phase II trial was done to determine whether local administration of GM-CSF augments immunogenicity of a multipeptide vaccine. It also assessed immunogenicity of administration in one versus two vaccine sites.Experimental Design: One hundred twenty-one eligible patients with resected stage IIB to IV melanoma were vaccinated with 12 MHC class Irestricted melanoma peptides to stimulate CD8+ T cells plus a HLA-DRrestricted tetanus helper peptide to stimulate CD4+ T cells, emulsified in incomplete Freund's adjuvant, with or without 110 g GM-CSF. Among 119 evaluable patients, T-cell responses were assessed by IFN- ELIspot assay and tetramer analysis. Clinical outcomes were recorded.Results: CD8+ T-cell response rates to the 12 MHC class Irestricted melanoma peptides (by day 50) with or without GM-CSF were 34 and 73, respectively (P < 0.001), by direct ELIspot assay. Tetramer analyses corroborated the functional data. CD4+ T-cell responses to tetanus helper peptide were higher without GM-CSF (95 versus 77; P = 0.005). There was no significant difference by number of vaccine sites. Three-year overall and disease-free survival estimates (95 confidence interval) were 76 (67-83) and 52 (43-61), respectively, with too few events to assess differences by study group.Conclusions: High immune response rates for this multipeptide vaccine were achieved, but CD8+ and CD4+ T-cell responses were lower when administered with GM-CSF. These data challenge the value of local GM-CSF as a vaccine adjuvant in humans. (Clin Cancer Res 2009;15(22):703644)

Rising costs and lowered reimbursements make value essential if laparoscopic cholecystectomy (LC) is to be offered to patients without condemning providers to financial loss. We hypothesize that our protocol increases this value. Once practiced, operative time, complications, and patient satisfaction compare with those of the typical method.We prospectively randomized 50 consecutive patients equally to control or experimental LC according to our protocol. Equipment costs, operative time, conversions, complications, pain, and return to work were compared. The student's t test was used for comparisons.Mean disposable equipment costs were 173.00 dollars +/- 43.45 dollars and 434.42 dollars +/- 50.54 dollars for the study and control groups, respectively (P.0001). Mean operative times were 67.26 +/- 15 and 70.60 +/- 19 minutes, respectively.The "bare bones" protocol is safe. It has a short learning curve, demonstrates a cost advantage over the common method, and requires no additional operative time. Pain, time to return to work, and satisfaction are equivalent.

Background: Immediate breast reconstruction is often performed after mastectomy for breast cancer. There has been concern that this will result in a delay in initiating chemotherapy and, as a consequence, may adversely impact survival. In this study we sought to determine whether immediate breast reconstruction affects the interval between surgery and adjuvant chemotherapy. Methods: A single institution retrospective analysis was made using the institutional tumor registry and chart reviews. Results: Forty-nine patients were identified who had undergone mastectomy with immediate reconstruction followed by adjuvant chemotherapy. They were compared with 308 patients undergoing mastectomy without reconstruction. Patients who underwent reconstruction were overall younger (46 versus 55, P

11054 Background: Molecular profiling of breast cancer (BC) identifies intrinsic subtypes with distinct gene expression and clinical characteristics. In the US, BC is less frequent in African-American females (AAF); however mortality is higher, particularly among younger women. Unfavorable subtypes of BC seem to be more frequent in premenopausal AAF. Methods: Tumor gene expression in AAF presenting with early stage or locally advanced BC was performed using the Symphony platform on fresh and paraffin-embedded tissue (Agendia inc), a microarray-based method which classifies tumors according to prognosis (MammaPrint, MP), molecular subtype (BluePrint, BP) and estrogen receptor (ER), progesterone receptor (PR) and Human Epidermal Growth Factor Receptor 2 (HER2) mRNA levels (TargetPrint, TP). Genomic information is correlated with clinical and pathologic characteristics and Oncotype DX recurrence score (RS) when available. We plan to enroll 100 patients. Results: Results available in 46 patients. Median age 62 years (range 24-100), 20 stage I, 15 stage II, 11 stage III disease. There was no significant association between MP risk and stage, but MP risk was significantly associated with grade 3 disease (p=.006). 9 cancers were triple negative by IHC; using BP, 8 of these were Basal-type and 1 HER2-type. Basal-type was the most common subtype in patients ≤ 40 years old (p < .001). In the 6 cases ER positive by IHC but negative by TP, 3 were Basal-type and 3 were HER2-type.14 patients had Oncotype RS results available: 2 were High Risk by Oncotype and MP; 3 had intermediate RS, 2 of which were High Risk by MP; 9 had a low RS, 4 of which were High Risk by MP. Conclusions: African-American women with stage I to III BC often present with High-Risk disease irrespective of stage. BP classified all young patients (≤40) as Basal-type. Molecular subtyping confirmed the biologic heterogeneity in triple negative and hormone positive tumors. Oncotype RS and MP offered different prognostic information. Follow up will be needed to determine correlation with outcome. Funding: MP, BP and TP test provided by Agendia. Biostatistical support by GHUTTCS-CTSA. [Table: see text]

Optimal treatment of skin cancer before it metastasizes critically depends on early diagnosis and treatment. Imaging spectroscopy and polarized remittance have been utilized in the past for diagnostic purposes, but valuable information can be also obtained from the analysis of skin roughness. For this purpose, we have developed an out-of-plane hemispherical Stokes imaging polarimeter designed to monitor potential skin neoplasia based on a roughness assessment of the epidermis. The system was utilized to study the rough surface scattering for wax samples and human skin. The scattering by rough skin-simulating phantoms showed behavior that is reasonably described by a facet scattering model. Clinical tests were conducted on patients grouped as follows: benign nevi, melanocytic nevus, melanoma, and normal skin. Images were captured and analyzed, and polarization properties are presented in terms of the principal angle of the polarization ellipse and the degree of polarization. In the former case, there is separation between different groups of patients for some incidence azimuth angles. In the latter, separation between different skin samples for various incidence azimuth angles is observed.

3008 Background: GM-CSF administered locally with vaccines can augment T-cell responses in animal models. Human experience with GM-CSF has mostly occurred in uncontrolled or nonrandomized trials. Thus, a multicenter prospective randomized phase II trial was performed to determine whether local administration of GM-CSF augments immunogenicity of a multipeptide vaccine administered in an emulsion with an incomplete Freund's adjuvant (IFA). A second component of the trial was designed to assess whether the vaccine administered in two sites is more immunogenic than in a single site. Methods: 121 eligible and evaluable patients with resected stage IIB-IV melanoma were administered a sequence of multipeptide vaccines, each consisting of 12 MHC Class I-restricted melanoma peptides (12MP) to stimulate CD8+ T cells, plus an HLA-DR restricted tetanus helper peptide to stimulate CD4+ T cells. Peptides were emulsified with IFA, with or without GM-CSF. T cell responses were assessed by IFN-gamma ELIspot assay and tetramer analysis, weekly x 8. Clinical outcome was evaluated for all patients. Results: Vaccination was well-tolerated, and each peptide was immunogenic. Overall CD8+ T-cell response rates to the 12MP (days 1–50), for patients vaccinated with or without GM-CSF were 43% and 75%, respectively (p < 0.001), and response magnitude was almost twice as high in patients without GM-CSF. Class I MHC tetramer analyses corroborated the functional data. There was also a greater CD4+ T-cell response to the tetanus helper peptide without GM-CSF than with it (95% and 77%, respectively, p = 0.005). There was no significant difference in immune response rates by the number of vaccine sites. For the entire patient group, 3-year overall and disease-free survival estimates [95% CI] were 76% [67, 83%] and 52% [43, 61%], respectively. There have been too few events to assess differences in clinical outcome by study arm. Conclusions: High immune response rates were achieved with this multipeptide vaccine, but CD8+ and CD4+ T-cell responses appear to be partially suppressed with addition of GM-CSF. These data challenge the value of local GM-CSF as a vaccine adjuvant in humans. [Table: see text]