Annual Meeting Proceedings Part 1 - American Society of Clinical ...

410s Health Services Research
6114 General Poster Session (Board #10G), Mon, 1:15 PM-5:15 PM
Impact of oncology drug shortages on patient treatment. Presenting Author:
Daniel Jacob Becker, St. Luke’s-Roosevelt and Beth Israel Medical Center,
Continuum Cancer Centers of New York, New York, NY
Background: Cancer drug shortages increased considerably over the past 5
years, but quantitative analyses of the scope and effects are limited. We
assessed the effects of drug shortages on outpatient medication use in a
single New York City university hospital. Methods: We examined pharmacy
records for drug shortages, defined by the ASHP as supply issues that affect
“how the pharmacy prepares or dispenses a drug product or influences
patient care when prescribers must use an alternative agent.” We examined
outpatient records for all cancer patients treated with infusional antineoplastic
and/or supportive medications from 4/2010-9/2010 and from 4/2011-
9/2011, and performed subgroup analysis on Aug/Sept 2011, the peak of
medication availability problems at our hospital. We compared proportions
of patients treated with specific medications in 2010 and 2011 with
Pearson’s chi-square test. Results: Twelve medications were in shortage
during the study period in 2010 and 22 in 2011. Between 4/1/10 and
9/30/10, 335 cancer patients were treated, and 379 patients were treated
between 4/1/11 and 9/30/11. Median patient age was 60 years. Cancer
site of origin was comparable between years: breast (40%), GI (15%),
lymphoma (10%), GU (8%), and lung (7%). Drugs considered in shortage
were used for 170 (50.8%) patients in 2010 and 241 (63.6%) patients in
2011 (p�0.0005). Of 235 patients treated in Aug/Sept 2011, there were
23 (9.8%) documented therapy changes due to shortages, compared with
0 changes among 211 patients treated in Aug/Sept 2010 (p�0.0001).
Among patients treated in Aug/Sept 2010 24 (11.4%) patients received
paclitaxel and 19 (9.0%) received docetaxel. Among patients treated in
Aug/Sept 2011, 11 (4.7%) received paclitaxel and 38 received docetaxel
(16.2%), a 69% decrease for paclitaxel and 80% increase for docetaxel
from 1 year prior (p�0.009, and p�0.024, respectively). The estimated
cost of a single treatment with paclitaxel for 1 patient with BSA 1.75 was
$47.59 versus $858.39 for docetaxel, a 1704% increase. Conclusions:
Oncology drug shortages affected the majority of patients in our center and
increased at an alarming rate. Drug shortages have substantial economic
costs and mandate treatment changes that may affect efficacy and toxicity.
6116 General Poster Session (Board #11A), Mon, 1:15 PM-5:15 PM
Pregnancy outcomes in women with cancer. Presenting Author: Andrea
Milbourne, University of Texas M. D. Anderson Cancer Center, Houston, TX
Background: Parenthood after cancer is a critical concern for many cancer
patients (pts). Pregnancy (prg) during cancer is an emotional time for about
1/1000 pregnant women. No randomized controlled studies exist examining
the impact of cancer treatment (tx) on the developing fetus nor on the
woman with cancer. Methods: From 2002-2011, women presenting for
cancer tx during prg were approached for this IRB-approved prospective
database study. All pts provided written consent. Results: To date 143 pts
are evaluable. The median age at diagnosis was 32.1 years and median
gestational age (GA) at enrollment was 18.2 weeks. 95/143 (66.4%) are
White, 19 (13.3%) are African American, 17 (11.9%) are Hispanic and 12
(8.4%) are Asian/Other. Primary cancers included breast (n�59, 41.3%),
hematologic (n�29, 20.3%), melanoma (n�13, 9%), GYN (n�11, 8%),
GI (n�8, 5.6%), head/neck (n�7, 6%) and other (n�16, 11%) (brain�4,
GU�1, thyroid�3, head/neck�7, thoracic�1, sarcoma�6, unknown primary�1).
111/143 (77.6%) of prgs resulted in live births. Median birth
weight was 6.5 lbs. Median follow-up time for pts was 32.3 months. To
date, 3/19 pts who terminated prgs have died (1.6%). Most terminations
occurred in the 1st trimester. To date, 79 pts (55.2%) are NED and 23 pts
have died; of these 19 (1.7%) had live births. No major malformations were
observed in the 74/143 (52%) of pts who received chemotherapy (CTx)
during pregnancy. 57% received FAC/FEC; other regimens included ABVD
(n�5), cytarabine (n�5), CHOP/R-CHOP, and platinum-based regimens.
Median GA at the start of CTx was 19.7 wks. Median number of CTx cycles
during prg was 4. Other pts underwent surgery (n�32), no tx (n�14),
deferred tx until after delivery (n�17), radiation (2), transplant (3), other
(1). Conclusions: Cancer diagnosis during prg is compatible with successful
tx and prg outcome. Cancer tx during the 2nd and 3rd trimester can be
safely given and in our pts did not result in adverse prg outcomes. Tx during
the 1st trimester is usually not recommended. Thus cancer pts in their 1st
trimester need to be extensively counseled about their disease as well as
about the risks to the prg. In our pts continuation or termination of prg were
not associated with an increased risk of death.
6115 General Poster Session (Board #10H), Mon, 1:15 PM-5:15 PM
Participation of teenagers and young adults (TYA) in cancer clinical trials
(CCT): What can we learn from six years of accrual data in England?
Presenting Author: Lorna Anne Fern, University College Hospitals London,
London, United Kingdom
Background: We reported underrepresentation of TYA in CTT in England,
2005-06. Since 2005 national healthcare policies and research initiatives
aimed at increasing participation of TYA in CCT have been implemented.
We aimed to determine if this has improved accrual rates (AR). Methods: We
analyzed accrual by age during 2005-2010 to UK Cancer Research
Network interventional trials recruiting newly diagnosed patients (pts) with
leukaemia, lymphoma, bone/soft tissue sarcoma, central nervous system
and germ cell tumours. AR were expressed as the ratio of pts entered onto
trial compared to population incidence cases for 2005-08; for 2009-10,
mean incidence of 2005-08 was used. Results: 2005-10 showed an AR
increase of 10.3% for pts 10-14 yrs, 17.9% for pts 15-19 yrs but only
4.6% for pts 20-24 yrs (Table). In 2010 AR was 54.4% for pts 10-14 yrs,
43.3% for 15-19 yr olds and 20.6% for pts 20-24. Annual increases of AR
were observed for pts 15-19 yrs, but in no other age groups, 0-59 yrs. We
looked at AR for children and younger teenagers , 5-14 yrs, vs older TYA,
15-24 yrs. Overall, AR for 5-14 yr olds was greater, 53.7% vs 23.0% for pts
15-24 yrs; however, during 2005-10 AR increased by 9.7% for pts aged
15-24 compared to 7.8% for pts aged 5-14. Conclusions: AR for TYA has
improved in between 2005-10. Most benefit is evident for older teenagers;
AR for young adults remain disappointing. Changes relate to increased trial
availability and access, centralisation of care for TYA, amendments to age
eligibility criteria to reflect tumour biology and increased collaboration
between adult and paediatric clinical research groups. Strategies to
improve AR for young adults require further development.
Number recruited (R), incidence (I), and AR for pts 0-24 yrs.
0-4 5-9 10-14 15-19 20-24
R I AR R I AR R I AR R I AR R I AR
2005 203 350 58.0 129 249 51.8 107 243 44.0 99 388 25.5 84 524 16.0
2006 207 352 58.8 132 245 53.9 120 276 43.5 110 361 30.5 67 519 12.9
2007 225 356 63.2 115 212 54.2 111 237 46.8 110 358 30.7 58 565 10.3
2008 243 317 76.7 149 204 73.0 131 242 54.1 121 341 35.5 76 558 13.6
2009 200 345 58.0 129 230 56.1 115 252 45.6 144 364 39.6 104 543 19.2
2010 232 345 67.2 132 230 57.4 137 252 54.4 158 364 43.4 112 543 20.6
%D 9.2 5.6 10.3 17.9 4.6
6117 General Poster Session (Board #11B), Mon, 1:15 PM-5:15 PM
Financial burdens (FB), quality of life, and psychological distress among
advanced cancer patients (ACP) in phase I trials and their spousal
caregivers (SC). Presenting Author: Fay J. Hlubocky, University of Chicago
Pritzker School of Medicine, Chicago, IL
Background: FBs have been identified as a significant predictor of stress for
cancer patients and their caregivers/partners. FBs may indirectly affect the
quality of life and psychological distress of clinical trial subjects, particularly
those with advanced disease on Phase I trials. Methods: A convenience
sample of ACP enrolling in phase I trials was assessed at baseline (T1) and
one month (T2) using several measures including: depression (CES-D),
state-trait anxiety (STAI-S/T), quality of life/qol (FACIT-Pal), and global
health (SF-36). Data on FB were obtained via the questions of Ell (2008),
querying subjects on: employment status, unexpected medical costs,
concerns regarding wages (e.g. termination, use of sick time), and financial
stress. Results: 104 subjects (52 Phase I ACPs and 52 SC) were separately
interviewed at T1 and T2. For the total population: median age 61
(28-78y); 50% male; 100% married; 87% Ca; 67%� HS educ; 55% GI
dx; 53% income �$65,000 yr, with45% ACPs employed full/part-time;
55% retired; 66% SC employed full/part-time with 34% retired. At T1,
82% of ACP reported medical cost concerns and 79% reported financial
stress. For SC at T1, 69% reported medical costs concerns; 83% employed
SC reported wage concerns; and 81% reported financial stress. For both
ACP and SC, rates remained consistent with the exception of increased
self-report re medical cost concerns at 85% and 72% respectively at T2. At
T2, ACP who reported unexpected medical costs had higher STAI-S (31 �
10v29�12, p�0.02) and CES-D scores (12 � 11v10� 9, p�0.04). SC
with self-reported financial stress had higher STAI-S anxiety (39 � 17v35
� 13, p�0.03) at T2. In regression analyses, ACP with medical costs
concerns had poorer FACIT-Pal QOL over time. Also, SC with medical cost
concerns at T2 was negatively associated with SF-36 scores. ACP and SC
qualitative responses re FBs revealed salient themes: insurance coverage,
unexpected costs associated with research study participation, Medicare,
bankruptcy, and worry re financial stability after ACP death. Conclusions:
FBs are negatively associated with quality of life among clinical trial
subjects and SC in phase I trials.
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