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

604s Patient and Survivor Care
TPS9150 General Poster Session (Board #51H), Sat, 8:00 AM-12:00 PM
Randomized phase III trial to evaluate radiopharmaceuticals and zoledronic
acid in the palliation of osteoblastic metastases from lung, breast,
and prostate cancer: Report of RTOG 0517. Presenting Author: Michael J.
Seider, Akron City Hospital, Akron, OH
Background: Skeletal related events (SREs) diminish quality of life (QOL) as
well as overall survival (OS) in patients with bone metastases, a common
event in breast, lung and prostate cancer. SREs can be reduced or delayed
by the use of bisphosphonates. It is postulated that the radiopharmaceuticals,
Strontium-89 (Sr89) and Samarium-153 (Sm153), when added to a
bisphosphonate can decrease the incidence of SREs. Methods: RTOG 0517
randomized patients with breast, lung and prostate cancer and blastic bone
metastases to either Zoledronic acid (ZA) alone or ZA plus a single standard
dose of either Sr89 or Sm153. No limitations were placed on additional
therapy such as chemotherapy or hormonal treatment. The projected
median time to SRE [pathological bone fracture, spinal cord compression,
surgery to bone, or radiation to bone] for the ZA arm was 10.4 months
requiring 257 SRE events to detect a 33% relative reduction for the
radiopharmaceutical arm in the time to development of an SRE with 90%
power. Other study objectives included quality of life, pain control, OS and
toxicity. Results: 261 patients (median age 68; 62% male; 55% prostate,
35% breast, 10% lung) were accrued from July 2006 through February
2011 (4.6 patients/month). Due to a lower than expected rate of SREs in
the control (ZA) arm, the study was closed early and therefore did not reach
the targeted accrual. 28 (17.4%) patients in the ZA arm and 27 (16.8%) in
the radiopharmaceutical arm experienced an SRE. Median time to development
of an SRE in the ZA and radiopharmaceutical arms was 11.60 and
16.74 months, respectively (p�.47). Median OS in the ZA arm and
radiopharmaceutical arm was 15.95 and 11.18 months, respectively
(p�0.12). Cox proportional hazards regression model showed that baseline
characteristics, including gender, race, ethnicity, primary disease site or
number of bone metastases, had no significant impact on OS. There was no
difference in QOL parameters or toxicities between the two arms. Conclusion:
Patients receiving ZA only experienced a much lower SRE rate than
was hypothesized. The addition of Sr89 or Sm153 did not result in a
difference in SREs, OS, or QOL
TPS9152 General Poster Session (Board #52B), Sat, 8:00 AM-12:00 PM
Radioprotection study of topical norepinephrine in postsurgical breast
cancer patients. Presenting Author: James F. Cleary, University of Wisconsin,
Madison, WI
Background: This study derives from radiodermatitis studies in a rat model
evaluating radioprotection from topical norepinephrine application. In the
model, increasing radiation doses induce dermatitis of increasing severity,
ranging from mild erythema to wet desquamation. The model was initially
designed to identify topical radioprotectants that function as oxygen free
radical scavengers. In an experiment designed to test the hypothesis that
the co-application of a topical vasoconstrictor and an aminothiol scavenger
would limit the systemic uptake of the scavenger, it was observed that the
combination was synergistic and that the topical vasoconstrictor was active
when administered alone as a control. Subsequent experiments demonstrated
that topical a-adrenergic receptor agonists are active in preventing
radiodermatitis. The data are consistent with a mechanism based on local
and transient vasoconstriction within the skin, which reduces local tissue
oxygenation. This subsequently limits the formation of radiation-induced
reactive oxygen species and protects skin stem cells from radiation
damage. Methods: Two Phase 1 safety studies have been conducted, one in
normal volunteers and one in cancer patients receiving palliative radiation
therapy for bone metastases. This study is a nonrandomized, open-label
safety and exploratory study in post-surgical breast cancer patients treated
with 45 to 50 Gy to the whole breast and axilla. A 10-16 Gy boost to the
lumpectomy region is permitted. Eligible patients are age 18 years or older
with a diagnosis of Stage Ia (T1, N0, M0), Stage Ib (T0 or 1, N1mic, M0) or
Stage IIa (T�3cm, N0, M0) infiltrating ductal or lobular carcinoma of the
breast or ductal carcinoma in situ (DCIS). The dose is a single daily topical
application of 3.0 mL of norepinephrine HCl (82.3 mg/mL in 70% ethanol)
applied to the same 50 cm2 treatment site in the axilla about 20 minutes
prior to each radiotherapy fraction. The radiodermatitis severity at the
treatment site will be compared to surrounding (untreated) control areas. 5
of planned 12 patients have been enrolled. Clinical trial registry number
NCT01263366.
TPS9151 General Poster Session (Board #52A), Sat, 8:00 AM-12:00 PM
Do we need to perform pulmonary function tests in non-small cell lung
cancer patients never diagnosed as COPD? Presenting Author: Narongwit
Nakwan, Prince of Songkla University, Hatyai, Thailand
Background: Although chronic obstructive pulmonary disease (COPD) and
lung cancer share a common risk factor, namely smoking, health care
providers usually overlook the symptom of COPD in the management of
lung cancer. Should, then, lung cancer patients undergo pulmonary
function tests (PFT) to identify the presence of COPD? Our study was
performed to describe the results of pulmonary function tests and define
risk factors for COPD in non-small cell lung cancer (NSCLC) patients.
Methods: A total of 31 eligible patients with NSCLC but no obvious
symptoms of COPD participated. We collected baseline characteristics and
conducted a detailed assessment of pulmonary function, particularly
spirometry, lung volume measurement, and diffusing capacity of carbon
monoxide (DLCO). Dyspnea was assessed using modified Borg (mBorg) and
modified Medical Research Council (mMRC) scores. Results: Twelve
patients had airflow limitation (FEV1/FVC�0.7). These patients had mean
percent predicted FEV1, RV and DLCO of 52%, 143% and 66% respectively,
and a mean RV/TLC of 0.55. Being male, and having a smoking
history, low body mass index and squamous cell carcinoma were significantly
associated with obstruction in univariate analysis. However, obstruction
was not more common in advanced stage than in locally advanced
NSCLC. Neither mBorg nor mMRC differed between obstructive and
non-obstructive groups. Discussion: COPD was found in patients with
NSCLC who had never been diagnosed as, or showed symptoms of, COPD.
Male, smoking history, low BMI and squamous cell carcinoma were
significantly associated with obstruction.
TPS9153 General Poster Session (Board #52C), Sat, 8:00 AM-12:00 PM
A multi-site, fixed dose, parallel arm, double-blind, placebo controlled,
block randomised trial of the addition of infusional octreotide or placebo to
regular ranitidine and dexamethasone for the evaluation of vomiting
associated with bowel obstruction at the end of life. Presenting Author:
David C. Currow, Flinders University, Adelaide, Australia
Background: Bowel obstruction due to advanced cancer that is surgically
inoperable is a major management problem. Studies to date have either
been underpowered or have used comparators that may not draw on the
best available evidence. Methods: This double-blind, block randomised,
placebo controlled, set dose, parallel arm study was conducted across 12
sites in Australia. Eligibility included inoperable bowel obstruction secondary
to cancer or its treatments. The intervention was the addition of
infusional octreotide or placebo in addition to 200mg ranitidine per 24
hours parenterally and 4mg per 24 hours parenterally of dexamethasone.
The primary outcome measure was the numbers of days free of vomiting up
to 72 hours after all medications were administered the first time.
Participants were also administered between 10-20mls per hour of
subcutaneous isotonic fluid over the 72 hour period. Results: This study
will close to recruitment in March 2012. To date 89 of 92 required
participants have been randomised. Conclusions: This adequately powered
study will define the additional net clinical benefit derived from octreotide
over placebo in people who have an anti-secretary agent (ranitidine) and
glucocorticoids (dexamethasone).
Visit abstract.asco.org and search by abstract for the full list of abstract authors and their disclosure information.