Total Dose Of Chemotherapy Research Articles

Improving ambulatory infusion drug delivery through alarm management using a quality improvement model and team learning.

472 Background: A quality outpatient cancer program depends on the accurate delivery of chemotherapy using a computerized ambulatory infusion pump to deliver a therapeutic dose of chemotherapy for patients. Between April and July 2021, our cancer center hotline reported an excessive rate of 60% of ambulatory pump were generating alarms. This resulted in interruptions in dose delivery, disruptions in clinical workflows, and negatively impacted patient satisfaction. Methods: A multidisciplinary team of frontline nurses, pharmacists, nurse leaders, and quality specialists was assembled to analyze six months of alarm data using a plan-do-study-act (PDSA) model. Quality tools were utilized to determine the root cause of the alarms and arrive at solutions to improve drug delivery by reducing alarms and calls to the infusion hotline. The team discovered 49% (n=22/45) of alarm could not be resolved, resulting in a dose interruption of the planned chemotherapy infusions. Patients returned to the infusion suite without receiving the total dose of chemotherapy as ordered. A full 70% of the hotline calls (n=16/22) were due to a “No Disposable” alarm code. Analysis of these returned units by both our group and the vendor led us to recommend a more advanced replacement model which was implemented in June/July of 2022. Results: Between July and December 2022, MCI outpatient ambulatory pump medication variances related to “No Disposable” improved by 100%. A total of 34 calls were received by the Hotline Nurse with 91% (31/34) of calls were successfully resolved. None of the ambulatory patients experienced an interruption in chemotherapy drug delivery. Conclusions: Forming a multidisciplinary working group resulted in a timely and significant improvement in chemotherapy safety using the PDSA model of quality improvement. Most importantly, confidence in chemotherapy drug delivery using ambulatory infusion pump was expressed by infusion nurses, pharmacists, and medical providers.

607. COMPARISON OF RECURRENCE PATTERNS AND SURVIVAL AFTER NEOADJUVANT CHEMORADIOTHERAPY VS. CHEMOTHERAPY FOR ESOPHAGEAL CANCER, A MULTI-CENTER EUROPEAN COHORT STUDY

Abstract Curative treatment for esophageal cancer requires local and systemic disease control. Neoadjuvant treatment increases long-term survival, but the evidence to date is insufficient to determine if neoadjuvant chemoradiotherapy (nCRT) with focus on local control or neoadjuvant chemotherapy (nCT) with focus on systemic control, is more beneficial. In this analysis of the ENSURE study we aimed to compare recurrence patterns and survival between nCRT and nCT in a large multicenter European cohort study. All patients treated with neoadjuvant therapy and esophagectomy for cancer from 2009-2015 in the ENSURE study (NCT03461341) were included. Univariable and multivariable logistic regression and Cox proportional hazard models were used to compare recurrence pattern, diseases-free, and overall survival. Results are shown as odds ratios (OR), hazard ratios (HR) and 95% confidence intervals (CI). The multivariable model was pre-specified and included age, sex, clinical tumor stage, and tumor histology. In total 3267/4682 (69.8%) patients were treated with neoadjuvant therapy and were included in the study. nCRT was given to 1798 (55.0%) patients, and nCT was given to 1496 (45.0%) patients. Median age for nCRT was 63 vs. 64 for nCRT, 65.5% in the nCRT group had adenocarcinoma vs. 81.4% in the nCT group. In the nCRT group 38.7% of patients had tumor stage III-IV compared to 61.3% in the nCT group. Multivariable adjusted OR for local recurrence comparing nCRT to nCT was 1.31 (95% CI: 1.08-1.59), distant recurrence OR 1.87 (95% CI: 1.57-2.22), and combined recurrence 1.49 (95% CI: 1.26-1.76). Adjusted HR for disease specific survival comparing nCRT to nCT was 1.38 (95% CI: 1.24-1.55), disease free survival: 1.39 (95% CI: 1.25-1.54), and for overall survival: 1.44 (95% CI: 1.30-1.60). The results of the study show significantly increased risk for recurrent disease and decreased survival after nCRT compared to nCT for esophageal cancer. nCRT is administered with a lower total dose of chemotherapy compared to nCT. Radiotherapy is given for local control, which is also achieved with adequate lymphadenectomy. The results indicate that effective systemic treatment with nCT might be beneficial compared to nCRT in curative intended treatment of esophageal cancer.

Identifying patient characteristics associated with chemotherapy-induced peripheral neuropathy (CIPN) severity in a phase II clinical trial: A retrospective analysis.

e24067 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of chemotherapy agents such as platinum, taxanes, vinca alkaloids, and bortezomib. Currently, as no effective prevention strategy is available, chemotherapy delay, reduction, and discontinuation are often necessary due to worsening CIPN. Our retrospective study aimed to identify patient characteristics associated with CIPN during neoadjuvant or adjuvant weekly paclitaxel chemotherapy in patients with early-stage breast cancer. Methods: We retrospectively collected baseline data from the screening phase in a phase IIA trial of weekly acupuncture intervention in women with early-stage breast cancer (ClinicalTrial.gov NCT02364726); the primary outcome was reported previously. Baseline data including age; body mass index (BMI); gender; race; CIPN severity; hemoglobin; hemoglobin A1c; TSH; vitamins B6, B12, and D levels; and anxiety and depression were retrospectively extracted from the electronic medical record (EMR) on the first day of treatment or up to four months prior to chemotherapy initiation. CIPN severity was measured by the Common Terminology Criteria for Adverse Events v4.0. Chemotherapy relative dose density (RDI) was calculated by total chemotherapy dose received divided by the total chemotherapy dose planned; disease recurrence and mortality rate were collected at the time of analysis. Logistic regression was used for statistical analysis. Results: A total of 105 patients’ baseline characteristics were extracted from the EMR. Baseline BMI was associated with CIPN severity (odds ratio [OR] 1.08; 95% confidence interval [CI] 1.01-1.16, p= 0.04). No significant correlations were observed in other covariates. At the median follow-up of 61 months, there were 12 (11.4%) breast cancer recurrences and 8 (7.6%) breast cancer-related deaths. Chemotherapy RDI was associated with disease-free survival (DFS, OR 1.026; 95% CI 1.00-1.05; p= 0.028). Conclusions: In this retrospective analysis, increased BMI was associated with worsening CIPN severity. Chemotherapy RDI was associated with improved DFS. Our findings suggest that baseline BMI may be a risk factor for CIPN. Additionally, suboptimal chemotherapy delivery due to CIPN maybe negatively impact DFS in patients with breast cancer. Further study is warranted to identify risks for CIPN.

How to select the most appropriate adjuvant treatment after neoadjuvant treatment and resection for locally advanced pancreatic cancer?

Adjuvant chemotherapy (ACT) significantly improves survival of patients undergoing upfront surgery for resectable pancreatic cancer. After introducing the concept of neoadjuvant therapy (NAT) with potent chemotherapy regimens, long term survival has been achieved even in patients with borderline and locally advanced pancreatic cancer (BR/LAPC) following radical resection. The observed pathologic tumor response is strongly predictive of survival and provides a unique opportunity to visualize to what extent the cancer has been sensitive to the administered chemotherapy regimen and may potentially give hint how to personalize further oncologic treatment. Current literature provides only limited and heterogeneous data as to whether and what type of ACT is beneficial after NAT and resection for BR/LAPC. Larger studies suggest that ACT may bring survival advantage and should be attempted particularly in node-positive disease and preferably with more potent regimen such as FOLFIRINOX, if tolerable. In case of complete pathologic response, particularly after FOLFIRINOX, it does not seem beneficial to deescalate the treatment during ACT, but whether continuation on the same regimen is worthwhile needs to be further examined. In case of gemcitabine-based treatment as NAT, continuation with more cycles seems to be of value unless tumor biology proves to be too aggressive, with high lymph node ratio. Whether switch to a different regimen should be sought, if tolerability allows it, needs to be further studied. Whether it is the exact treatment sequence (NAT, ACT or both) of the potent chemotherapy regimens like FOLFIRINOX and gemcitabine-nab-paclitaxel or the total dose of chemotherapy that has impact on survival in BR/LAPC, is unknown.

Prognostic Impact of Postoperative Lymph Node Metastases After Neoadjuvant Chemoradiotherapy for Locally Advanced Squamous Cell Carcinoma of Esophagus: From the Results of NEOCRTEC5010, a Randomized Multicenter Study.

To determine the prognostic impact of pathologic lymph node (LN) status and investigate risk factors of recurrence in esophageal squamous cell carcinoma (ESCC) patients with pathologic complete response (pCR) after neoadjuvant chemoradiotherapy (NCRT). There are no large-scale prospective study data regarding ypN status and recurrence after pCR in ESCC patients receiving NCRT. The NEOCRTEC5010 trial was a prospective multicenter trial that compared the survival and safety of NCRT plus surgery (S) with S in patients with locally advanced ESCC. The relationships between survival and cN, pN, and ypN status were assessed. Potential prognostic factors in patients with ypN+ and pCR were identified. A total of 389 ESCC patients (NCRT: 182; S: 207) were included. Patients with pN+ in the S group and ypN+ in the NCRT group had decreased overall survival (OS) and disease-free survival (DFS) compared with pN0 and ypN0 patients, respectively. Partial response at the primary site [hazard ratio (HR), 2.09] and stable disease in the LNs (HR, 3.26) were independent risk factors for lower DFS, but not OS. For patients with pCR, the recurrence rate was 13.9%. Patients with distant LN metastasis had a median OS and DFS of 16.1 months and 14.4 months, respectively. Failure to achieve the median total dose of chemotherapy was a significant risk factor of recurrence and metastasis after pCR (HR, 44.27). Persistent pathologic LN metastasis after NCRT is a strong poor prognostic factor in ESCC. Additionally, pCR does not guarantee a cure; patients with pCR should undergo an active strategy of surveillance and adjuvant therapy.

LBA22 - Trilaciclib improves overall survival when given with gemcitabine/carboplatin (GC) in patients with metastatic triple negative breast cancer (mTNBC) in a randomized phase II trial

LBA22 - Trilaciclib improves overall survival when given with gemcitabine/carboplatin (GC) in patients with metastatic triple negative breast cancer (mTNBC) in a randomized phase II trial

USE OF FEMORAL ARTERY ULTRASOUND DURING INTRAARTERIAL CHEMOTHERAPY FOR CHILDREN UNDER 10 KG WITH RETINOBLASTOMA.

To demonstrate the safety and efficacy of intraarterial chemotherapy (IAC) in small infants (<10 kg) with retinoblastoma. Retrospective, consecutive, observational case series of patients treated with IAC. Femoral arterial access was obtained using a micropuncture kit and ultrasound guidance, which enabled direct visualization. Melphalan (1.5-5.0 mg), topotecan (0.3-2.0 mg), and/or carboplatin (30-40 mg) were used. Patients underwent adjuvant therapies including laser, cryotherapy, and intravitreal melphalan if persistent disease or recurrence was observed. Fifty-nine injections were administered to 11 eyes of 6 patients. All eyes but one were classified as International Classification Groups C or D. Median patient weight at first IAC cycle was 9.2 kg (mean, 8.9 kg). Median diameter of the femoral artery at the catheterization site was 3.74 mm, measured by two independent observers. Median follow-up was 21.4 months (range 13.1-34.5 months). All eyes were salvaged. This study confirmed the safety and efficacy of IAC in infants under 10 kg. Ultrasound guidance enabled successful catheterization of femoral arteries as small as 2.7 mm in diameter. Patients in this study appeared to require fewer injections and lower total doses of chemotherapy compared with previously reported series of comparably advanced disease in larger infants.

Chemoradiotherapy as Definitive Treatment for Elderly Patients with Head and Neck Cancer.

Background With the aging population and a rising incidence of squamous cell carcinoma of the head and neck (SCCHN), there is an emerging need for developing strategies to treat elderly patients. Patients and Methods We retrospectively analyzed 158 patients treated with definitive, concurrent chemoradiotherapy (CRT) for SCCHN. Clinicopathological characteristics, acute toxicities, and oncological outcomes were compared between patients younger and older than (or of age equal to) 65, 70, and 75 years. Results RT dose, chemotherapy regimen, and total chemotherapy dose were balanced between the groups. After a median follow-up of 29 months, overall survival (OS), progression-free survival (PFS), local control rate, and distant metastasis-free survival stratified by age of ≥65, ≥70, or ≥75 years revealed no differences. The rate of acute toxicities was also not higher for older patients. Worse ECOG performance score (ECOG 2-3) was associated with impaired OS (p = 0.004) and PFS (p = 0.048). Conclusion Definitive treatment with CRT for SCCHN is feasible and effective; even in advanced age treatment decisions should be made according to general condition and comorbidity, rather than calendar age alone.

Assessment of the potential impact of dose rounding parenteral chemotherapy agents on cost savings and drug waste minimization.

Background Fiscally responsible utilization of anticancer treatments is necessary to combat their continually increasing cost. Dose rounding is one strategy that has been explored to minimize cost and waste without losing clinical effectiveness. Objectives To determine if dose rounding chemotherapy agents is a feasible cost-containment strategy at an institution with a small oncology clinic. Methods This study is a retrospective chart review of all body surface area dosed parenteral chemotherapy prescribed for an oncological diagnosis over a 12-month period (1 October 2015-30 September 2016). Chemotherapy doses were rounded down by 5%. Doses for patients with metastatic diagnoses were also rounded down by 10%. Rounded doses were evaluated for a potential decrease in vial size. Cost was represented as dollar/milligram of drug. Potential for drug waste minimization was also calculated. Results There were 877 total doses of chemotherapy administered to 70 unique patients throughout the 12-month duration of the study. When doses were rounded down by 5%, 140 doses qualified for a decrease in vial number. The potential for cost savings was $22,849 with 83,802 mg saved from wastage. A 10% decrease resulted in the reduction of vials for 248 doses, a potential savings of $30,911 with 129,011 milligrams saved. The targeted agents accounted for the majority of savings, $16,920 of the $22,849 with 5% rounding and $20,086 of the $30,911 with 10% rounding. Conclusion Dose rounding has the potential to be an effective cost-containment strategy in low volume oncology clinics.

Abstract 3427: Split-dose R-CHOP: A novel approach to administer cytotoxic chemotherapy to geriatric patients with DLBCL

Abstract Introduction Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma. R-CHOP 21 (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone given in 21 day cycles) is the standard chemotherapy for DLBCL. Due to age-related comorbidities, this regimen may be too toxic for the geriatric population. At our institution we have developed a modified regimen for the frail elderly termed split-dose R-CHOP (SD R-CHOP). Patients (pts) receive CHOP at a 50% dose reduction on day 1 and day 15 of each 28 day cycle. Rituximab is given at full dose on day 1 of each cycle. The total amount of chemotherapy delivered during each 28 day cycle of SD R-CHOP is equivalent to the total doses in R-CHOP 21. All pts are supported with G-CSF after each half cycle. Methods We performed a cohort study of DLBCL pts treated with SD R-CHOP since 2007 at our institution. International prognostic index (IPI) and Charlson Comorbidity Index (CCI) were calculated retrospectively for all pts. Descriptive and survival analyses using the Kaplan-Meier methodology and univariate Cox-Proportional hazard models were performed. The primary endpoints, overall survival (OS) and progression free survival (PFS) were estimated from the date of first SD R-CHOP to death, progression, or end of follow-up. Results We identified 20 pts with DLBCL treated with SD R-CHOP. The median age was 82 (range 60 to 90 years) and 70% were female. 14 pts had an elevated LDH and 13 pts had stage III/IV disease. Pts had a mean IPI of 3 and a mean CCI score of 2. Of the 20 pts, 9 completed prescribed treatment and achieved a complete response on post-treatment imaging. Of the remaining 11 pts, 2 are in the midst of treatment, 3 died during treatment, and 6 required further modification of treatment due to infectious complications or organ toxicity. The cause of death in those three pts included pulmonary emboli (N = 1), progressive lymphoma (N = 1), and myocardial infarction (N = 1). 13/20 pts required hospitalization during chemotherapy. The median OS for all pts treated with SD R-CHOP was 47 months and the median PFS was 43 months. For the 9 pts who completed treatment, the median OS was not reached and the PFS was 50 months. Univariate Cox analysis revealed that age, sex, elevated LDH, CCI, IPI, and stage of disease did not impact OS. However, pts who did not complete their prescribed therapy had a hazard ratio (HR) for OS of 5.7 (95% CI 1.2 to 27.3, p = 0.03) and those who were hospitalized had a HR for OS of 5.9 (95% CI 0.74 to 46.6, p = 0.09). Conclusions The treatment of aggressive DLBCL in older patients remains a challenge in geriatric oncology. Our SD R-CHOP approach allowed administration of the same total chemotherapy dose as R-CHOP 21 in a geriatric population felt not to be fit for the standard regimen. With this dose modification patients who were able to complete therapy achieved durable responses. We plan to validate these results in a larger prospective trial. Citation Format: Nirav Shah, Nandita Mitra, Joshua Brikman, Sunita Nasta, Daniel Landsburg, Anthony Mato, Dan Vogl, Noelle Frey, Stephen Schuster, Jakub Svoboda. Split-dose R-CHOP: A novel approach to administer cytotoxic chemotherapy to geriatric patients with DLBCL. [abstract]. In: Proceedings of the 106th Annual Meeting of the American Association for Cancer Research; 2015 Apr 18-22; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Res 2015;75(15 Suppl):Abstract nr 3427. doi:10.1158/1538-7445.AM2015-3427

Reduced Dose Intensity of Chemotherapy may not Lead to Inferior Palliation in Locally Advanced Carcinoma of the Gall Bladder: An Experience from a Regional Cancer Centre in Eastern India.

To assess impact of relative total dose intensity (RTDI) on clinical benefit among patients with locally advanced carcinoma gall bladder receiving gemcitabine-cisplatin (GemCis). Comparison of clinical benefit among patients receiving variable RTDI was the primary objective. The secondary objective was an impact of RTDI on chemotherapy toxicity. One-hundred twenty-one patients with locally advanced inoperable carcinoma gall bladder undergoing chemotherapy with three weekly gemcitabine-cisplatin chemotherapies (gemcitabine 1000 mg/m(2) on day 1 and 8, cisplatin 70 mg/m(2) on day 1) were studied. Clinical benefit and treatment toxicity was assessed. Total dose of chemotherapy and relative total dose intensity, the proportion of planned dose actually received was calculated. RTDI of at least 50 % conferred substantial clinical benefit compared to lower RTDI (75.49 vs. 21.05 %). RTDI above 50-59 % did not improve clinical benefit; two-tailed p values of RTDI >60 % vs. RTDI >50 % and RTDI >70 % vs. RTDI >50 % were 1.000 and 0.4266, respectively. Subsequent extended cholecystectomy rates did not significantly improve among patients who received RTDI greater than 50-59 %; two-tailed p values of RTDI >60 % vs. RTDI >50 % and RTDI >70 % vs. >50 % were 0.0920 and 0.5648, respectively. Significantly higher neutropenia and anemia of at least grade 2 occurred with RTDI >70 % vs. RTDI 50-59 %; two-tailed p values 0.0019 and 0.0048, respectively. Relative total dose intensity of chemotherapy higher than 60 % among patients with inoperable locally advanced carcinoma gall bladder conferred no significant improvement in clinical benefit and subsequent rates of extended cholecystectomy. Higher RTDI however led to significantly increased toxicity among these patients.

Abstract P3-14-20: Neoadjuvant chemotherapy in young age breast cancer: Survival benefit over adjuvant chemotherapy in clinically T2 node positive patients

Abstract Background: The downstaging of the primary tumor and the increase in breast conservation rates seems to be the only clinical benefit of Neoadjuvant systemic therapy(NST) in breast cancer treatment, given that several studies failed to demonstrate an improvement of overall survival compared with postoperative adjuvant chemotherapy. In Europe, S6 trial showed better early outcome in survival in favour of the neoadjuvant chemotherapy group compared to adjuvant chemotherapy group in premenopausal patients without significantly modifying long-term event rates. The aim of this study was to assess a potential advantage in survival by neoadjuvant as compared to adjuvant chemotherapy in young age breast cancer patients. Methods: Between January 2001 and December 2008, 1169 consecutive patients with breast cancer aged under 40 underwent adjuvant chemotherapy before or after surgery. Prospectively collected medical records for all patients were reviewed retrospectively. For the comparison of survival between neoadjuvant versus adjuvant chemotherapy group, cinically T2 and node positive patients were retrieved. Survival curves were derived from Kaplan-Meier estimates and compared by log-rank test. Results: Of the 1169 patients, 203(17.3%) patients were treated with neoadjuvant chemotherapy, and they were grouped as ‘NST’ and ‘non-NST’ according to initial treatment. About 47% patients in each group were clinically T2 patients. (99(47.8%) in NST group, 453(46.9%) in non-NST group) Among them, clinically T2 and node positive patients were 188, 97 patients in NST group, 91 patients in non-NST group each. The median age was 35.11±3.9 years old and HER2 amplification was observed as 23.5%, and they were not different between two groups.(p = 0.146 and 0.941 each) Significant lower hormone receptor expression rate and higher Ki-67 level were observed in NST group(p = 0.03 and &amp;lt;0.0001 each) Breast conservation surgery rate was also significantly different between two groups, more favorable results in NST group.(67% in NST group, 37.4% in non-NST group, p&amp;lt;0.0001) During median follow-up period of 61 months (range 44 to 148 months), we observed a statistically significant difference (p = 0.011) in survival in favour of the NST group. This benefit of survival was presented consistently regardless of hormone receptor expression. A similar trend was seen when the time to distant disease recurrence was evaluated (p = 0.176). And this trend was more prominent in hormone receptor negative patients, but still not statistically significant. (p = 0.144) The mean total dose of chemotherapy administered was similar in both groups. Improved survival figures in the NST group could be the result of the early initiation of systemic treatment, but the trend in favour of decreased metastases was not statistically significant. Conclusion: A potential advantage of primary over adjuvant chemotherapy in young age breast cancer patients’ survival might be proposed by this results. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-14-20.

A Phase II, randomized, double-blind study of zibotentan (ZD4054) in combination with carboplatin/paclitaxel versus placebo in combination with carboplatin/paclitaxel in patients with advanced ovarian cancer sensitive to platinum-based chemotherapy (AGO-OVAR 2.14)

BackgroundIn platinum-sensitive relapsed ovarian cancer, paclitaxel plus carboplatin is a standard second-line treatment. Zibotentan (ZD4054) is an oral, specific ETA-receptor antagonist with demonstrated antitumour activity in xenograft models of human ovarian cancer. MethodsIn this Phase II, randomized, placebo-controlled study, patients with relapsed ovarian cancer sensitive to platinum-based chemotherapy received zibotentan 10mg or placebo once-daily, plus paclitaxel 175mg/m2 iv followed by carboplatin iv (AUC 5) on day 1 of every 3-weekcycle for a maximum of eight cycles. The primary endpoint was progression-free survival (PFS), evaluated by Response Evaluation Criteria In Solid Tumours (RECIST). Secondary and exploratory endpoints included objective tumour response rate, tumour size, CA-125/RECIST progression, and safety and tolerability. ResultsA total of 120 patients were randomized (zibotentan: n=59; placebo: n=61). Addition of zibotentan 10mg/day to carboplatin and paclitaxel did not improve PFS compared with placebo (median PFS, 7.6 versus 10.0months, respectively; HR=1.46, [80% CI: 1.10–1.94]; P=0.0870). No improvements in any of the secondary or exploratory efficacy endpoints were observed for patients receiving zibotentan compared with placebo. Median duration of total treatment exposure was 6.7months. Total chemotherapy dose received was lower for zibotentan-treated versus placebo-treated patients (carboplatin: −16%; paclitaxel: −14%). The most common adverse events in the zibotentan arm were anaemia, nausea, alopecia, headache and neutropenia (43–48% of patients). ConclusionsZibotentan 10mg/day plus carboplatin and paclitaxel did not result in an improvement in PFS compared with chemotherapy alone in patients with advanced ovarian cancer sensitive to platinum-based chemotherapy. No unexpected safety concerns were identified.

Obese Patients Have Improved Survival Following Autologous Hematopoietic Stem Cell Transplantation

AbstractAbstract 1989High-dose chemotherapy followed by autologous stem cell transplant can improve long-term outcome of patients with hematologic malignancies. Outcomes following transplant are variable. Obesity has implications for stem cell mobilization, chemotherapy administration, and medication dosing. We analyze the impact of obesity on transplant outcomes including neutrophil recovery, platelet recovery, length of hospital stay, and survival.From 1/2004 to 12/2009, 573 patients underwent autologous stem cell transplant. From these patients, 17 were excluded due to incomplete data. Of the remaining 556 patients, the median age was 53 years, and 346 (62%) were male. The diagnoses were 286 (51%) non-Hodgkin lymphoma, 161 (29%) multiple myeloma, 91 (16%) Hodgkin lymphoma, and 18 (3.2%) other. A majority of these patients (93%) had received 3 or less prior chemotherapy regimens. Most patients (76%) had not received prior radiation therapy. Most patients had chemosensitive disease (92% were in complete or partial remission) at time of transplant. For stem cell mobilization regimen, 376 (68%) received chemotherapy and G-CSF, 176 (32%) received G-CSF alone, and 4 (<1%) received G-CSF and Plerixafor. For a preparative regimen, 360 (65%) received busuflan/etoposide/cyclophosphamide, 125 (23%) received melphalan, and 71 (13%) received busulfan/cyclophosphamide.Patients were categorized into four groups based on the body mass index (BMI): underweight (BMI<18.5), normal (18.5–24.9), overweight (25.0–29.9), or obese (≥30.0). Using these definitions, there were 5 (1%) underweight, 133 (24%) normal, 188 (34%) overweight, and 230 (41%) obese patients. Underweight and normal were combined into a single group due to the small number of underweight patients. Baseline and transplant characteristics of these patients are listed in Table 1. Variables were compared among BMI groups using the Chi-square test (categorical variables), Kruskal-Wallis test (continuous variables), or log-rank test (survival). Cox proportional hazards analysis was used to identify prognostic factors for survival.On univariable and multivariable analyses, obese patients demonstrate better survival than those who are not obese (hazard ratio 0.73, P=0.026; Figure 1).In conclusion, obesity has no impact on neutrophil or platelet recovery, length of transplant hospitalization, or 100-day mortality. Obese patients appear to have improved overall survival. The reasons for this are unclear, but may have to do with higher total dose of chemotherapy for the preparative regimen. Although obesity is associated with many co morbidities and possibly more aggressive disease, these patients do not have cancer cachexia and may have other protective benefits.Table 1Patient and transplant characteristics according to BMIUnderweight/ Normal N = 138Overweight N = 188Obese N = 230VariableN (%)N (%)N (%)P-valueGenderMale63 (46)136 (72)147 (64)<0.001Female75 (54)52 (28)83 (36)Age, yearsMedian (range)50 (20–74)55 (20–73)54 (19–75)0.013Number of prior chemotherapy regimens≤ 3130 (94)177 (94)212 (92)0.65>38 (6)11 (6)18 (8)Prior radiation therapyYes38 (28)45 (24)53 (23)0.61No100 (72)143 (76)177 (77)DiagnosisNHL74 (54)98 (52)114 (50)0.025MM28 (20)53 (28)80 (35)HL33 (24)30 (16)28 (12)Other3 (2)7 (4)8 (4)Disease status at transplantCR/PR120 (87)172 (91)217 (94)0.048Active disease18 (13)16 (9)13 (6)Mobilizing regimenG-CSF+chemotherapy106 (77)126 (67)144 (63)0.05G-CSF alone32 (23)61 (32)83 (36)G-CSF + Plerixafor0 (0)1 (0.5)3 (1)Preparative regimenBu/VP/Cy94 (68)128 (68)138 (60)0.22Melphalan30 (21)34 (18)61 (27)Bu/Cy14 (10)26 (14)31 (13)CD34+ dose, × 106/kgMedian (range)6.19 (2.11–47.97)5.67 (2.06–65.18)7.01 (1.62–51.90)0.21Days to ANC > 500Median (range)11 (9–13)11 (9–17)10 (9–15)0.36Days to platelet > 20,000Median (range)14 (6–129)14 (5–432)14 (3–46)0.48Length of hospital stayMedian (range)21 (13–30)20 (13–74)20 (12–37)0.08100-day mortalityYes9 (7)9 (5)4 (2)0.06No129 (93)179 (95)226 (98) [Display omitted] Disclosures:No relevant conflicts of interest to declare.

Does age matter in achieving optimum chemotherapy delivery in managing head and neck cancer with primary chemo-radiotherapy?

Purpose of the study: Older patientswith head and neck cancermay be denied the potentially beneficial addition of chemotherapy to primary radiotherapy in the management of head and neck cancer, because of fears that older patients will develop relatively more treatment related morbidity and not tolerate treatment, when compared to younger patients. This could lead to breaks in, or discontinuation of radiotherapy giving poorer outcomes for survival and local control in older patients. Methods: We have reviewed a cohort of 141 head and neck cancer patients who had definitive primary chemo-radiotherapy over the period 2007–2009 in our department, and examined whether patients 65 years of age and over received as much chemotherapy as those patients below 65 years and why patients in both groups, did not receive the total chemotherapy dose prescribed. Results: Despite the younger patient group having a better performance status and lower ACE 27 (Adult Co-morbidity Evaluation 27) score, both younger and older groups received comparable total doses of chemotherapy. There were similar admission rates during chemo-radiotherapy for treatment-related morbidity, number of inpatient days, number of multiple admissions and incidence of febrile neutropenia, in both older and younger patient groups. Conclusions: Our study suggests that older patients, with head and neck cancer, where the use of chemotherapy is appropriate, can tolerate primary chemo-radiotherapy as well as younger head and neck cancer patients, and that older patients should not be denied chemotherapy on the basis of presumed increased morbidity.

Serial comprehensive geriatric evaluation in older head and neck cancer patients undergoing radiotherapy

Purpose of the study: Older patientswith head and neck cancermay be denied the potentially beneficial addition of chemotherapy to primary radiotherapy in the management of head and neck cancer, because of fears that older patients will develop relatively more treatment related morbidity and not tolerate treatment, when compared to younger patients. This could lead to breaks in, or discontinuation of radiotherapy giving poorer outcomes for survival and local control in older patients. Methods: We have reviewed a cohort of 141 head and neck cancer patients who had definitive primary chemo-radiotherapy over the period 2007–2009 in our department, and examined whether patients 65 years of age and over received as much chemotherapy as those patients below 65 years and why patients in both groups, did not receive the total chemotherapy dose prescribed. Results: Despite the younger patient group having a better performance status and lower ACE 27 (Adult Co-morbidity Evaluation 27) score, both younger and older groups received comparable total doses of chemotherapy. There were similar admission rates during chemo-radiotherapy for treatment-related morbidity, number of inpatient days, number of multiple admissions and incidence of febrile neutropenia, in both older and younger patient groups. Conclusions: Our study suggests that older patients, with head and neck cancer, where the use of chemotherapy is appropriate, can tolerate primary chemo-radiotherapy as well as younger head and neck cancer patients, and that older patients should not be denied chemotherapy on the basis of presumed increased morbidity.

The Attitudes, Communication, Treatment, and Support Intervention to Reduce Breast Cancer Treatment Disparity

to test the effect of a supportive, one-time psychoeducational intervention on treatment adherence among African American women receiving first adjuvant therapy for breast cancer. a pilot, randomized, controlled clinical trial, two-group design, with one-time intervention and four data collection points. two University of Pittsburgh Cancer Institute clinics. 24 African American women. the Attitudes, Communication, Treatment, and Support (ACTS) intervention is a 45-minute one-on-one session with an African American woman recommended to have chemotherapy for breast cancer. The interventionist is an African American breast cancer survivor. The intervention consists of a discussion about chemotherapy and the importance of communicating knowledge needs and distress, an explanation of the specific treatment plan according to pathology, and support through the survivor testimonial and video clips from the African American community. dose of chemotherapy received and dose of chemotherapy prescribed. Twenty patients completed chemotherapy, and four chose not to begin or discontinued recommended chemotherapy. The groups were equal in key sociodemographic variables. Compared to usual care, the ACTS intervention participants demonstrated trends toward initiation of chemotherapy (100% versus 82%), overall adherence to chemotherapy (92% versus 73%), and percentage of total dose of chemotherapy received or prescribed (94% versus 74%). Compared to usual care, the ACTS intervention participants demonstrated more rapid initiation of chemotherapy and better overall adherence to chemotherapy. the pilot ACTS intervention shows promise as a psychoeducational intervention to assist with chemotherapy decision making among African American women. African American women are at high risk of not receiving the full dose of prescribed chemotherapy for breast cancer for multiple reasons. Nurses must be sensitive to the unique fears and concerns of this population regarding chemotherapy decisions. An intervention addressing these fears and concerns may help to increase adherence.

Feasibility and Efficacy of ABVD In Elderly Hodgkin Lymphoma Patients: Analysis of Two Randomized Prospective Multicenter Trials of the German Hodgkin Study Group (HD10 and HD11)

AbstractAbstract 418About 20% of all patients with first diagnosis of Hodgkin Lymphoma (HL) are older than 60 years. They have a poor prognosis mainly due to an increased toxicity of chemo- and radiotherapy. Although resulting in better disease control, aggressive regimens as BEACOPP are not feasible in this cohort of patients due to a treatment related mortality of up to 20%. Therefore, ABVD is considered treatment of choice for elderly HL patients, although prospective studies are lacking and current concepts mostly rely on cohort analyses. We therefore analyzed feasibility, safety and outcome of patients older than 60 years with early favorable- or early unfavorable-stage HL treated with 4 cycles of ABVD within the HD10 and HD11 trials of the GHSG. Sixty-eight and 49 elderly patients with a median age of 65 and 64 years were treated in HD10 and HD11, respectively. Early termination of protocol therapy was documented in 18% of HD10 patients, but only in 8% of HD11 patients, resulting in a lower relative total chemotherapy dose (RCD) in HD10. The relative dose intensity (RCD divided by total relative chemotherapy duration) was much lower in both studies compared to younger patients, due to more toxicity-related therapy delays and dose reductions, as 4 cycles of ABVD caused WHO grade III/IV toxicities in 67% (HD10) and 69% (HD11). Overall efficacy was significantly lower than in younger patients with an overall response rate of 90% in HD10 and 92% in HD11. The rate of relapsing patients was the same as in younger patients in HD11 (14%), whereas in HD10 it was much higher in the elderly (12%) which was mainly due to late relapses. Overall 22% and 37% of the patients died in HD10 and HD11, respectively (median observation time: 92 months). Besides other causes as cardiovascular disease (7%) or secondary neoplasia (5%), there was a high rate of deaths due to insufficient HL-control (5%) and treatment-related toxicities (5%). The 5-year PFS estimates for elderly patients were 79% (95% CI, 67% to 87%) in HD10 and 69% (95% CI, 54% to 80%) in HD11 compared to 96% (95% CI, 93% to 97%) and 86% (95% CI, 83% to 88%) for younger patients in HD10 and HD11, respectively. In conclusion, 4 cycles of ABVD are effective in elderly HL patients; however, treatment-related toxicity is high. Disclosures:No relevant conflicts of interest to declare.

A Retrospective Analysis of Clinical Outcomes of Patients Older Than or Equal to 80 Years with Small Cell Lung Cancer

The optimal treatment for patients older than 80 years with small cell lung cancer (SCLC) is unknown. A retrospective chart review was conducted for 45 patients aged 80 years or older with SCLC, and therapeutic indices and toxicities of anticancer treatment were compared with those of 38 patients aged 70 to 79 years. Subgroup analyses according to the levels of performance status (PS) and comorbidity were also performed. Twenty-four (53%) of the 45 patients underwent combination chemotherapy and/or thoracic radiotherapy, which resulted in significant survival benefit compared with those left untreated (p < 0.01). The main reasons for not administrating anticancer treatments were advanced age (>85 years), poor PS, and severe comorbidities. The average total chemotherapy dose delivered was 60% of the intended protocol dose. Median survival time and 1-year survival of the treated patients were 13.0 months and 57% for limited disease and 10.3 months and 40% for extensive disease, respectively. Despite a lower chemotherapy dose being administered, survival indices were similar to those of patients aged 70 to 79 years. Survival benefit was observed even in the treated patients with PS 2 to 3 or a moderate degree of comorbidity compared with those left untreated. The frequency of grade 3 to 4 hematologic toxicities was not significantly different between the two age groups. The standard chemotherapy regimen with or without thoracic radiotherapy seems to be feasible for patients older than 80 years with SCLC, even for those with PS 2 to 3 and/or moderate comorbidity, although frequent dose adjustment is necessary.

Peripheral nervous system and spinal cord involvement in lymphoma

Nine-hundred-eighty-nine patients with diagnosis of lymphoma were studied. Forty-six cases (4.6%) had compressions of the spinal cord or roots. Forty-two patients (4.2%) had Herpes zoster virus infections, which in 6 cases were of disseminated type. The major predisposing factors for infection were: advanced stage of lymphoma, previous systemic chemotherapy and splenectomy. Toxic polyneuropathy secondary to chemotherapy was found in 39 patients (3.9%). In 14 cases, the polyneuropathic symptoms were the main complaint (Group 1), while in the remaining 25 cases the diagnosis was made during neurological consultations because of unrelated symptoms (Group 2). Both groups did not have significant differences in the total dose of chemotherapy received. The electrophysiological studies showed an axonal neuropathy in both groups. The discontinuation of chemotherapy was found to be a limiting factor in the appearance of neuropathic symptoms. Other less frequent forms of involvement were: compression of peripheral nerves or nerve plexi from lymphadenopathies (3 cases), radiation myelopathy (1 case), and Guillain-Barré Syndrome associated with Hodgkin's Lymphoma (1 case).