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Annals of Oncology
demographic factors, magnitude of delay & subsequent prognostic losses incurred by
this population.
Methodology: The study included all breast cancer cases reporting for treatment &
permitting to be interviewed, in three medical colleges of Kolkata, India, between 1 st
Jan’2011 and 31 st Dec’2011. Patients initially treated by CAM were subjected to
detailed Questionnaires, focused on CAM professionals involved in the first medical
attention; Initial size of the tumor (Based on Lumpometer designed by TMH,
Mumbai); initial presence of nodal disease; history of Biopsy; demographic charters;
the perceived benefits of CAM; & the time & costs involved. They were then staged
and treated according to their present status.
Results: Analysis included 736 patients. Prior to reporting at the study centers
35.37% (260) patients opted for CAM. Analysis of this group revealed, 73.07 %
came from Rural areas; 67.3% had poor socio-economic status; 46.16% were
uneducated; none were screened or Biopsied. Homeopathy is the commonest
form of CAM resorted to 70.76 %; Ayurveda 9.6%; Quack Allopathy 16.15%;
Unani 1.92% & Spiritual Healing 1.53%.The median duration of symptoms at
the first visit to the CAM professional was10 weeks [2-18]. 65.38% had
non-tender breast lumps. The median initial T- Size was 2.5 cm [1-6.5]; median
time lost 9.3 months [1.5 -28] & median expenditures 980 Rs [150-3500]. The
median T-size at presentation to the study centers was 4.2 cm [2.8-12.5]. New
onset nodal disease was seen in 38.0 %; Changes in disease staging seen in 56.15
%. The reasons were overlapping, unaffordability 51.92 %; inaccessibility 34.61%;
38.46% feared disfigurement; homeopathy can liquefy tumors was reasoned by
30.76%.
Conclusion: With more than 1/3 of breast cancer patients still opting for CAM for
obvious reasons, none biopsied, valuable 9.3 months lost & 56% presenting upstaged,
the anticipated prognostic losses are unacceptably large.
Disclosure: All authors have declared no conflicts of interest.
1389P USE OF INTEGRATIVE THERAPIES IN BREAST CANCER
PATIENTS. HEALTH SERVICE RESEARCH IN A NETWORK OF
INTEGRATIVE ONCOLOGY
F. Schad 1 , J. Axtner 1 , A. Happe 1 , A. Voigt 2 , J. Gutsch 3 , G. Spahn 4 ,
C. Herbstreit 5 , M. Debus 6 , M. Kroez 1 , H. Matthes 7
1 Network Oncology, Research Institute Havelhoehe (FIH), Berlin, GERMANY,
2 Gynaecology, Hospital Herdecke, Herdecke, GERMANY, 3 Outpatient
oncologist, Gevelsberg, GERMANY, 4 Center for Integrative Medicine and Cancer
Therapies, Hospital Oeschelbronn, Niefern-Oeschelbronn, GERMANY,
5 Gynaecology, Hospital Havelhoehe, Berlin, GERMANY, 6 Medical Care Center
Havelhoehe, Outpatient Oncologist, Berlin, GERMANY, 7 Internal Medicine,
Hospital Havelhoehe, Berlin, GERMANY
Background: Diagnosis of breast cancer induces high emotional distress.
Integrative oncology (IO) responds to patients needs by offering a variety of nonpharmacotherapeutic
interventions (NPI) and Viscum album extracts (VA). VA
enhances health-related quality of life and reduces adverse effects caused by
conventional strategies, whereas NPI activate patients’ resources. In the present
study we evaluated the use of IO therapies in breast cancer patients from a clinical
registry.
Methods: We analyzed 3289 female patients collected by the Network Oncology, a
conjoint clinical registry of German hospitals and out-patient practitioners. We used
non-parametric Fisher exact test (F) to compare observed frequencies, Wilcoxon rank
sum (W), Kruskal-Wallis test (KW) for differences between groups. We fitted a
logistic regression model to explain use of VA and NMI.
Results: Mean age was 54.5 ± 11.7 and frequencies of UICC stages were 0: 71%, I:
31%, II: 41%, III: 15% and IV: 7%. 93% of the patients got VA and were in median
three years younger than non-VA patients (medVA= 52, W, p= 0.002). Median length
of VA was 4.11 years (1 st Q 0.13, 3 rd Q 7.42) and was neither influenced by UICC nor
age. Median time until start of VA after diagnosis was 7 month (1 st Q 2.31, 3 rd Q
17.43). Radiation, chemotherapy and surgery were significantly associated with
getting VA (β rad =1.07, p rad< 0.001; β che= 0.49, p che= 0.006; β sur= -1.47, p sur= 0.042).
68% of the patients got NPI (eurythmy 60%, massages 52%, embrocations 51%,
wrappings 51%, drawing 41%, modeling 13%, music 8%, psychological 6%, lymph
drainage 6% and hyperthermal therapy 2%) and choose in median 4 different NPI.
Frequencies of NPI quantities were affected by UICC stage (F, p< 0.001). Chemo
therapy, UICC IV, III and radiation were significantly associated with receiving NPI
(βche= -0.83, pche< 0.001; βIV =0.83, pIV= 0.001; βIII =0.62, pIII= 0.003; βrad= -0.28,
prad= 0.003).
Conclusions: In an IO setting VA and NPI are part of standard care and frequently
used by breast cancer patients. Conventional therapies are major predictors if
patients receive VA or NMI. Results suggest that health service research data provide
a solid data basis for warranted prospective studies on outcome related studies in IO.
Disclosure: H. Matthes: PD Dr. med. Harald Matthes is member of the board of
directors of the Weleda A.G. Arlesheim/ Switzerland. All other authors have declared
no conflicts of interest.
1390P PATIENT CHARACTERISTICS IN RENAL CELL CARCINOMA
AND DAILY PRACTICE TREATMENT WITH SORAFENIB
(PREDICT) IN CHINA
D-W. Ye 1 , J. Guo 2 , A. Zhou 3 , Y. Huang 4 ,H.Li 5 ,Z.Hu 6 ,C.Fu 7 , J. Liu 8 , M. Irwin 9 ,
J. Ma 10
1 Urologic Oncology Surgery, Fudan University Shanghai Cancer Center,
Shanghai, CHINA, 2 Oncology, Beijing Cancer Hospital, Beijing, CHINA, 3 Urologic
Oncology, Cancer Institute & Hospital, Chinese Academy of Medical Sciences,
Beijing, CHINA, 4 Urologic Surgery, Shang Hai Ren Ji Hospital, Shanghai, CHINA,
5 Urologic Surgery, Union Medical College Hospital, Beijing, CHINA, 6 Urologic
Surgery, Tongji Hospital, Huazhong University of Science and Technology,
Wuhan, CHINA, 7 Urologic Surgery, 7Liaoning Provincial Tumor Hospital,
Shenyang, CHINA, 8 Urologic Surgery, Huaxi Hospital of Sichuan University,
Chengdu, CHINA, 9 Medical, Bayer Healthcare Company Ltd, Beijing, CHINA,
10 Urologic Oncology Surgery, Cancer Institute & Hospital, Chinese Academy of
Medical Sciences, Beijing, CHINA
Background: Sorafenib is indicated for the treatment of the patients with advanced
renal cell carcinoma (RCC). This post-marketing surveillance study was to evaluate
patient characteristics in RCC patients as well as the efficacy and safety of Sorafenib
under daily-life treatment conditions after its regulatory approval.
Methods: This was a prospective, non-interventional, non-controlled multi-center
observational study (NCT00895674). Patients with advanced RCC and the
decision taken by the investigator to prescribe sorafenib were involved in the
study.
Results: A total of 1033 patients were enrolled. 963 patients were included in the
safety and 853 patients in the efficacy statistical analysis. Baseline characteristics were:
71% male; median age 53.0 years (17∼85 years); 91% ECOG 0-2; 88.3% clear-cell
histology; 24% high MSKCC risk; 30% >1 location of metastasis; 77.6 % prior
nephrectomy; 59.2% prior systemic anticancer treatment. 12.9% of patients had
pre-existing hypertension and 5.6% had diabetes mellitus. The median follow-up
time of this study was 10.0months (mos).A clinical benefit was observed for 72.8 %
of patients (n = 612/841) and radiologically for 71.0 % of patients (n = 597/841) at
the last follow-up visit. Median PFS was 10.0mos. The median duration of sorafenib
therapy was 10.0 mos, clinically relevant subgroups was as follows : > = 70 years
(7.6mos), without nephrectomy (7.9mos), not purely clear histologic subtypes
(7.3mos), >1 metastases site (8.6mos). There was no other demographic or baseline
characteristics revealing any considerable differences. Treatment was well tolerated.
97.7 % received a daily dose of 800 mg sorafenib, only 5.7% with dose reduction at
last visit. Drug-related adverse events (AEs) were 32.61%. The most commonly
reported AEs in this study were HFSR or Palmar-plantar erythrodysesthesia (19.4%),
rash (7.0%), diarrhea (6.9%), alopecia (4.7%), hypertension (3.0%) and fatigue
(1.5%). Most of the AEs reported were mild to moderate (72.1%) according to
CTCAE.
Conclusions: This study has shown baseline characteristics and safety of advanced
RCC patients treated with sorafenib in Chinese real world setting. The results suggest
that sorafenib is broadly beneficial for advanced RCC patients, regardless of baseline
clinical charateristics and prior cancer treatment.
Disclosure: All authors have declared no conflicts of interest.
1391P INTERPRETING OVERALL SURVIVAL (OS) RESULTS WHEN
PROGRESSION FREE SURVIVAL (PFS) BENEFITS EXISTS IN
TODAY’S ONCOLOGY LANDSCAPE - METASTATIC RENAL
CELL CARCINOMA (MRCC) CASE STUDY
S. Negrier 1 , Y. Tang 2 , C. Chen 3 , P. Bycott 2
1 Dept. of Oncology, Centre Léon Bérard, Lyon, FRANCE, 2 Statistics, Pfizer, Inc,
San Diego, CA, UNITED STATES OF AMERICA, 3 Global Outcomes Research,
Pfizer, Inc, New York, NY, UNITED STATES OF AMERICA
Background: New cancer treatments (tx’s) have clinical and health policy challenges
to demonstrate a survival benefit over active tx after showing a PFS benefit.
Subsequent tx and long post progression survival periods can lead to significant
variability posing hurdles in showing OS benefit. The objective of this analysis was to
examine the likelihood of OS benefit when a PFS benefit exists. We analyzed Phase
III (P3) AXIS 2nd line trial data of axitinib versus sorafenib in mRCC employing
methods described by Broglio et al 2009.
Methods: We conducted simulations investigating the OS and PFS relationship
utilizing the AXIS trial. OS was partitioned into 2 parts, expressed as the sum of PFS
and survival post progression (SPP). We assumed a median SPP ranging from 6 to
18 months. The actual observed trial pooled SPP was 12.9 months. Median SPP was
assumed equal in both arms. The impact on OS was directly reflective of PFS
translated into a survival benefit. We further assumed a median improvement in PFS
to 6.8 months in the axitinib arm from 4.7 months for sorafenib which translated
into a HR = 0.69, based on P3 results. By bootstrapping the censoring times the
simulations preserved and mimicked observed accrual, follow-up patterns, and
censoring percentage of the P3 trial.
Volume 23 | Supplement 9 | September 2012 doi:10.1093/annonc/mds410 | ix453