tbuckley/cabot-search huggingface dataset:
Is the second primary malignancy an important competing cause of death in patients (pts) with squamous cell head and neck cancer (SCHNC)?
Authors: E. Tso, D. J. Adelstein, L. A. Rybicki, J. P. Saxton, R. M. Esclamado, B. G. Wood, M. Strome, M. A. Carroll
Journal: Journal of Clinical Oncology (2004)

5516 Background: The development of a 2nd (or 3rd) primary malignancy (SPM) is a well recognized problem in pts with SCHNC. Although the prognosis of such pts is not well defined, SPM is felt to be an important competing cause of death. Methods: We retrospectively reviewed our registry of 222 SCHNC pts treated with definitive chemoradiotherapy (CRT) between 1989–2002, to identify those pts with SPM, and define their clinical characteristics and outcomes. All pts received 4-day continuous intravenous 5-fluorouracil (1000 mg/m2/day) and cisplatin (20 mg/m2/day) during the 1st and 4th weeks of either qd or bid radiation. Results: There were 55 SPM identified in 45 pts; 10 were synchronous and 45 were metachronous (13 before and 32 after the index SCHNC). The projected Kaplan-Meier (KM) cumulative incidence of SPM developing after the index SCHNC is 20% at 5 years. Of the 55 SPM, 35 (64%) were upper aerodigestive tract(UADT) cancers: 19 lung cancers (13 squamous cell), 13 SCHNC, and 3 esophageal cancers (1 squamous cell). There were 37 pts with SPM occurring synchronous or subsequent to the index SCHNC. When these 37 are compared to the other 185 pts with no synchronous or subsequent SPM, there is no difference in the 5-year KM overall survival (65% in both groups, P=0.37), at a median follow up of 55 (range 2–166) months. The survival curves subsequently diverge, however, with survival at 6 years of 51% vs. 62%, and at 7 years of 41% vs. 59% respectively. Once the diagnosis of a synchronous or subsequent SPM is made, the 3 year projected KM survival is 52%. There were 19 SPM of lung in 18 pts, all either synchronous with or subsequent to the index SCHNC. Eight (42%) were Stage I, and definitive treatment was possible in 12 of 18 pts. After diagnosis of a SPM of lung, these 18 pts had a 3-year KM projected survival of 55%. Conclusions: Pts treated for SCHNC are at risk for development of SPM, predominantly involving the UADT. The prognosis for these pts is better than expected, perhaps reflecting early diagnosis, and justifying aggressive management. The survival of pts in CRT trials reporting < 5 years of follow-up is not likely impacted by the development of a SPM. No significant financial relationships to disclose.
Effect of zoledronic acid on bone pain and skeletal morbidity in patients with advanced prostate cancer; analysis by baseline pain
Authors: J. Eastham, J. McKiernan, D. Gleason, M. Zheng, F. Saad
Journal: Journal of Clinical Oncology (2005)

4561 Background: Zoledronic acid (Zol) is the only bisphosphonate to significantly reduce skeletal-related events (SREs) and pain compared with placebo in patients (pts) with advanced prostate cancer and bone metastases. To further assess the benefit of Zol, this exploratory retrospective analysis evaluated the effect of Zol on the incidence of SREs based on baseline pain levels and pain. Methods: Zol 4 mg or placebo was administered to pts (N = 422) with prostate cancer every 3 weeks for up to 24 months. Bone pain was assessed using the Brief Pain Inventory (BPI) at 6-week intervals. Changes in BPI composite pain score (defined as the average of “worst pain,” “least pain,” and “average pain” over the last 7 days and “pain right now”) were analyzed based on presence of pain at baseline. For missing data, the last observation was carried forward. Results: Of 371 evaluable pts, 270 (73%) reported pain at baseline, with a mean baseline composite BPI score of ∼2.8 (range, 0 to 10) in both treatment groups. Among these pts, decreases from mean baseline pain scores of -10%, -4%, and -1% at months 3, 6, and 9, respectively, were reported in pts who received Zol compared with increases of 6%, 9%, and 13% from baseline in the placebo group (P = .021 at Month 3). During months 12 through 24, both groups had increased pain scores; however, Zol-treated pts had smaller increases (range, 1% to 6%) compared with placebo (range, 15% to 25%) and the between-group differences were statistically significant at Month 21 (P = .024) and Month 24 (P = .034). Further, Zol decreased the proportion of pts who developed an SRE by 9% and the mean annual incidence of SREs by 39% compared with placebo. Among 101 (27%) pts with no pain at baseline, mean pain scores increased in both treatment groups. Zol decreased the proportion of pts developing an SRE by 19% and the mean annual incidence of SREs by 49% compared with placebo. Conclusions: Zol provides reduction of SREs and pain in pts with bone metastases from prostate cancer regardless of the presence of baseline pain, suggesting that early and continued Zol treatment may improve quality of life in these pts. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis (employee) Novartis Novartis Novartis, Novartis Oncology Novartis
Triple-negative breast cancer: Epidemiology, characteristics, and survival in a Lebanese cohort
Authors: M. Ghosn, C. Hajj, F. Nasr, F. El Karak, G. Abadjian, J. Kattan, G. Chahine
Journal: Journal of Clinical Oncology (2009)

e22228 Background: Breast cancer (BC) is the most common malignancy in women in Lebanon. Triple negative (TN) phenotype is known to be associated with an increased likelihood of recurrence and death. The purpose of this study is to determine the incidence, characteristics and survival of TN BC patients in a Medical Oncology department in a University Hospital in Lebanon. Methods: We retrospectively reviewed the pathology of all women with breast cancer that were seen in our institution between 1997 and 2008. TN BC patients (pts) were defined as those that were negative for all 3 receptors (estrogen, progesterone and HER2neu on immunohistochemistry). Pts' characteristics and survival of TN women were analyzed. Results: Of the 1599 breast cancer pts, 155 (9.7%) had a triple negative phenotype. Median age was 52 years. A positive family history of breast/ovarian cancer was found in 15 pts (10%). Pathology studies showed: invasive ductal carcinoma component in 138 pts (89%), pure medullary carcinoma in 7 pts (5%), pure invasive lobular carcinoma in 6 pts (4%), pure mucinous carcinoma in 3 pts (2%) and epidermoid carcinoma in 1 pt (1%). A grade III was found in 98 of specimens (63%). Twenty-six pts (17%) presented with stage I, 73 (47%) with stage II, 37 (24%) with stage III and 19 (12%) with stage IV. Twelve percent had inflammatory breast cancer. After a median follow up of 17 months (mths), 43 pts had relapsed (5 stage I, 18 stage II and 20 stage III). The most common sites of relapse were brain (in 20 % of cases), lungs (in 20% of cases) and bone (in 11% of cases). Five- year disease free survival and 5-year overall survival were respectively 75% and 88% for stage I, 58% and 72% for stage II and 40% and 63% for stage III. Adjuvant therapy was administered to 96% of pts among which a taxane-based regimen was used in 38% of cases . Median survival for stage IV was 19 mths with a first line taxane-based regimen used in 50% of cases. Conclusions: The incidence of TN BC in Lebanon is similar to that described in the literature. It has an aggressive course. Focus on understanding the biology of this particular BC subtype is essential for determining targets for future therapeutic options. No significant financial relationships to disclose.
Stereotactic body radiotherapy (SBRT) in difficult-to-treat areas (para-aortic lymphadenoapthy and pelvic recurrence) in oligometastatic colorectal carcinoma.
Authors: Indrani Subarna Bhattacharya, David Woolf, Robert Hughes, Mark Harrison
Journal: Journal of Clinical Oncology (2015)

733 Background: Oligometastatic (OM) colorectal carcinoma (defined as three or fewer sites of isolated metastatic disease) may occur in potentially difficult to treat areas (including para-aortic lymphadenopathy and pelvic recurrence). Proximity of critical structures and previous irradiation may prove treatment of OM disease challenging. The aim of this study was to identify local control, overall survival (OS), and progression free survival (PFS) of patients receiving SBRT for difficult to treat oligometastatic disease (para-aortic lymphadenopathy and pelvic recurrence). Methods: Data were prospectively collected for patients receiving SBRT between 1/9/10-31/3/14, including demographic details, SBRT date, date of local/distant progression, toxicity, and date of death. Data was collected until 1/6/14. All patients were discussed within a specialist SBRT MDT and planned for treatment utilizing the Cyberknife (Accurray) treatment system. Treatment doses included 24 Gy/3F (22.7%), 27 Gy/3F (27.3%), 30 Gy/3F (13.6%), 30 Gy/5F (4.5%), 33 Gy/3F (22.7%), 36 Gy/3F (9.1%). Total dose was determined by surrounding normal tissue toxicities. Results: 9 received SBRT for para-aortic lymphadenopathy and 13 for pelvic recurrence. Median age was 58 (38-81) years. 14 were male. Median follow-up was 8.0 (0.5-28.0) months. 59.1% patients were treated within a prior radiotherapy treatment volume. 31.8% patients were disease free after SBRT. 63.6% had distant relapse and 4.5% had local and distant relapse. Local control was 95%. Median time to relapse was 4.5 (1.2-37.2) months. OS was 72% at 1 year and 46% at 2 years. PFS was 36% at 1 year and 27% at 2 years. Significant toxicities included 1 patient with duodenal ulcer formation following para-aortic node SBRT. Conclusions: Our prospective series confirms excellent local control (95%) with SBRT for OM colorectal carcinoma in areas considered to be difficult to treat, and with limited toxicity.
Analysis of the geographical distribution of cancer in Israel.
Authors: A. Zick, Y. Rottenberg, M. Barchana, M. Shirav-Schwartz, T. Peretz
Journal: Journal of Clinical Oncology (2010)

1604 Background: The Haifa subdistrict houses the city of Haifa and major industry facilities. The aim of the current study was to assess cancer incidence in the Haifa subdistrict vs. the rest of Israel using valid, personal data. The sample size enabled us to control for socio- demographic variables. Methods: A historical prospective study, with cohort inception and baseline measurement of people participating in the Central Bureau of Statistics (CBS) 1995 census, was designed. Cancer incidence was calculated in people residing in the Haifa subdistrict vs. a random sample of people residing in the rest of Israel in a 1:1 ratio, after adjusting for age, gender, ethnicity, continent of birth, education years and income per person. In addition, the 1996/7 and 1999 /2000 CBS health surveys, each of 28,000 people, were analyzed to assess smoking prevalence. To asses Cd soil concentration contribution to cancer incidence a geochemical analysis was performed. The Cd concentration in soil was sampled in 1800 points in Haifa and the West Galilee. An Arithmetic mean of Cd measurements in a census block (aCd) was calculated. Results: 175,704 people were included with a total of 8034 cancer cases. The hazard ratio (HR) to develop cancer comparing Haifa subdistrict with the rest of Israel is 1.12 (95% CI: 1.08- 1.23, p < 0.001) after adjusting for socio-demographic variables. The distribution of cancer sites is very similar to those caused by smoking such as lung (HR 1.29, 95% CI: 1.08-1.53, p < 0.004). Analysis of the 1996/7 and 1999 /2000 CBS health surveys demonstrates that in the Haifa subdistrict 21.5% and 21.8% people smoked vs. 23.3% and 23.2% in the rest of Israel (p = 0.068 and p = 0.192) respectively. aCd within the upper quartile (> 1.5 ppm) vs. the lower quartile (0 ppm) was associated with increase risk for cancer (HR 1.12, 95% CI: 1-1.28, p = 0.053) after adjusting for demographic variables. Conclusions: We conclude that there is an increased risk to develop cancer in the Haifa subdistrict not explained by socio-demographic variables or smoking. We report an increased cancer incidence in Cd rich areas within Haifa and the West Galilee. No significant financial relationships to disclose.
Smoking cessation is challenging even after lung cancer surgery
Authors: M. E. Cooley, L. Sarna, J. Kotlerman, J. M. Lukanich, M. Jaklitsch, R. Bueno
Journal: Journal of Clinical Oncology (2007)

19507 Background: It is recommended that patients undergoing lung cancer surgery quit smoking pre-operatively to reduce peri- operative complications. Smoking cessation after diagnosis is associated with improved clinical outcomes. Few studies have examined the behavior of surgical lung cancer patients who are smokers. We sought to 1) determine the smoking prevalence rate at diagnosis; 2) identify readiness to quit and cessation strategies, 3) describe patterns of smoking overtime, and 4) identify factors (demographic, tobacco-related, and health status) correlating with smoking relapse and/or continued smoking (SR) after surgery. Methods: Ninety-four patients were enrolled in a descriptive study. Data were collected through chart review and standardized tobacco and health status questionnaires. Smoking status was assessed through self-report and measurement of urinary cotinine. The primary endpoints were smoking status at 1, 2, and 4 months after surgery. Frequencies, t-tests, and chi-square were used for analysis. Results: Eighty-four patients (89%) were ever-smokers and 35 (42%) reported smoking at diagnosis. Twenty-nine (83%) current smokers attempted cessation at diagnosis and 18 (51%) received assistance with pharmacotherapy being the most common strategy. One month post-operatively, 20 (56%) self-reported smokers planned to quit within the following month. Fifty (60%) ever-smokers remained abstinent, 13 (15%) continued smoking, and 21 (25%) relapsed. Ten (48%) of those who relapsed were former smokers and had not smoked for at least a year before diagnosis. Factors significantly associated with SR included younger age, lower education and pain. Those who relapsed were on average 7 years younger (p=0.01). Those without high school education (HS) had a significantly higher rate of relapse as compared to those with at least HS (83% vs. 48%, p=0.04). Those with pain had a higher rate of relapse as compared to those who did not have pain (73% vs. 33%, p=0.03). Conclusions: Smoking relapse rates are high after lung cancer surgery even among those who previously quit. Former and current smokers are at high risk for relapse and will require smoking cessation programs incorporating symptom management and relapse prevention. No significant financial relationships to disclose.
Phase II trial of nab-paclitaxel (nanoparticle albumin-bound paclitaxel (ABX)) + capecitabine (XEL) in first-line treatment of metastatic breast cancer (MBC)
Authors: B. G. Somer, L. S. Schwartzberg, F. Arena, A. Epperson, D. Fu, B. V. Fortner
Journal: Journal of Clinical Oncology (2007)

1053 Background: ABX and XEL both have substantial single agent activity in MBC. Taxane and anti-metabolite doublets improve response rate and TTP and longer survival. ABX administered weekly has an excellent safety and efficacy profile with maintenance of dose intensity. This study was designed to test the safety and efficacy of ABX + XEL given in a novel combination schedule. Methods: This phase II, multicenter open label study utilized ABX 125 mg/m 2 IV on day 1, 8 and with no premeds and capecitabine 825 mg/m 2 PO BID days 1–14 on a Q 3 week cycle. The primary endpoint is objective response rate, with evaluation performed after every 2 cycles. Entry criteria include measurable MBC by RECIST criteria, age &gt;18, PS 0–2, no prior chemo for metastatic disease, &gt; 6 months since adjuvant fluoropyrimidine and/or paclitaxel. Results: The full sample of 50 patients (pts) have been enrolled; data from 43 pts are available for analysis. Median age is 58 (range 23.7–90.6). 37% received prior adjuvant anthracycline and 33% prior adjuvant taxane. Median number of metastatic sites is 2 (range 1–7), with most common sites of disease liver, 53.5%; bone, 51.2%; and lung, 14%. 226 cycles of therapy have been delivered. 5 pts required a dose reduction in XEL (3 pts to 650 mg/m 2 ; 2 to 550 mg/m 2 ) and 4 pts had dose reduction in ABX to 100 mg/m 2 . XEL dose reductions occurred due to hand-foot syndrome (3), neutropenia (1), and fatigue (1). ABX dose reductions occurred due to mucositis, diarrhea, fatigue, and neuropathy (1 pt each). 10 pts had grade 3–4 non-hematologic AEs: 3 hand-foot syndrome, 4 fatigue, and 3 GI. Hematologic AEs included 4 with grade 3 and 1 with grade 4 neutropenia, and 2 with grade 4 febrile neutropenia. The most common AEs of any grade were GI (30), dermatological (23), fatigue (15), neuropathy (12), and hand-foot syndrome (11). The incidence of Grade 1–2 neuropathy was 25% (no grade 3–4). Of 38 pts available for analysis of response, the overall response rate is 47.5%: PR 39.5%, CR 8%. Total of 15 pts have stable disease, 20 pts have completed 6+ cycles. No significant financial relationships to disclose.
Do newly diagnosed cancer patients require palliative care? An audit at a regional cancer center in India.
Authors: Sushmita Ghoshal Chakrabarti, Raviteja Miriyala, Arun Elangovan, Bhavana RAI
Journal: Journal of Clinical Oncology (2014)

65 Background: The present study was planned to record the distressing symptoms of newly diagnosed cancer patients and to evaluate how the symptoms were addressed by the treating oncologists. Methods: All newly diagnosed cancer patients referred to the department of Radiotherapy during the month of May 2014 were asked to fill a questionnaire after taking their consent. The ESAS-r questionnaire was used to assess the frequency and intensity of distressing symptoms. The case records of these patients were then reviewed to compare the frequency and intensity documented by the treating physician. The difference in the two sets of symptoms documented were statistically analysed by non-parametric tests using SPSS. Results: Eighty-nine patients participated in this study out of which only 19 could fill the questionnaire on their own. Anxiety was the commonest symptom (97.8%) followed by depression (89.9%), tiredness (89.9%) and pain (86.5%). The treating physicians recorded pain in 83.1% while the other symptoms were either not documented or grossly under reported. Anxiety was documented in 3/87 patients but depression was not documented in any. Tiredness was documented in 12/80 patients, loss of appetite in 54/77 patients mentioning them in the questionnaire. Significant statistical correlation could be seen between the presence of pain, anxiety, depression, tiredness and loss of appetite in the patients. Conclusions: The study reveals that the distressing symptoms experienced by newly diagnosed cancer patients are grossly under reported and inadequately addressed by treating oncologists. Sensitizing the oncologists and incorporating palliative care principles early in the management of cancer patients could improve their holistic care.
Usefulness of low-dose thalidomide for Japanese patients with refractory and relapsed multiple myeloma
Authors: H. Kanamori, S. Hashino, S. Takahashi, M. Onozawa, K. Kahata, T. Kondo, M. Asaka
Journal: Journal of Clinical Oncology (2007)

18543 Background: Thalidomide is not licensed in Japan, and many patients with multiple myeloma (MM) are therefore taking thalidomide that is imported from other countries. In this study, the effectiveness and side effects of thalidomide in patients with MM who took the drug from 2003 to November 2006 were retrospectively analyzed. Methods: Forty-one patients with refractory and relapsed MM were treated with thalidomide. The median age of the patients was 67.6 years (range,48 to 90 years) Most patients (88%) were treated at a dose of 100 mg/day, but the dose was later modified due to toxities, responses and monetary matters. Thalidomide was administered alone (n=21) and in combination with other drugs (n=20) such as dexamethasone. Results: Seventeen patients (41%) responded to thalidomide (nine patients (22%) showed a reduction in myeloma protein of over 50% and eight patients (19%)showed a reduction of 25–50%.). Kaplan-Meier estimates of overall survival were 68.6% at 1 year and 38.4% at 2 years.The 2-year overall survival rate was higher in ten patients who underwent autologous stem cell transplantation(P&lt;0.001). Low-dose thalidomide was tolerated well but thalidomide treatment had to be discontinued in two patients because of life-threatening interstitial pneumonitis (Onozawa et al. JCO 2005,23). Conclusions: Low-dose thalidomide is useful for treatment of advanced myeloma and can improve prognosis. However, thalidomide, even when administered at a low dose, can caese life-threatening toxicities, and attention must therefore be given to safe use of the drug. No significant financial relationships to disclose.
A phase II, single-arm study of AS1411 in metastatic renal cell carcinoma (RCC).
Authors: J. E. Rosenberg, H. A. Drabkin, P. Lara, A. L. Harzstark, R. A. Figlin, G. W. Smith, F. Erlandsson, D. A. Laber
Journal: Journal of Clinical Oncology (2010)

4590 Background: AS1411 is a DNA aptamer that targets nucleolin. Although normally present in the nucleolus, nucleolin is overexpressed and shows localization to the plasma membrane in renal and other cancer cells. A dose-escalating phase I trial of AS1411 monotherapy reported 1 complete response (CR) and 1 partial response (PR) among 12 patients with advanced RCC. A randomized phase II trial in AML reported increased CR rates when AS1411 was added to high-dose cytarabine. Methods: This phase II single-arm study evaluated AS1411 monotherapy in patients with metastatic, predominantly clear cell, RCC who had failed, or shown intolerance to, ≥1 prior treatment, including a tyrosine kinase inhibitor. AS1411 was administered at 40 mg/kg/day CI days 1-4 of a 28 day cycle for 2 cycles. Response evaluation using RECIST occurred every 8 weeks from the start of therapy until disease progression (performed by investigators and by an independent radiologist). The primary endpoint was response rate (CR+PR); progression-free survival (PFS), duration of response, and safety were secondary endpoints. Pharmacokinetic (PK) analysis was performed. Results: 35 patients were enrolled and treated; the median no. prior therapies was 2 (range 1-7). 33 completed 2 cycles of treatment. Independent response assessment indicated 1 PR (3%) and 21 cases of stable disease (SD; 60%); investigator assessment indicated 1 PR (3%) and 12 SD (34%). The patient achieving a PR exhibited a decreased sum of unidimensional target lesion measurements of ≥ 80%, and remains in PR at 5.9 months. Independently assessed median PFS was 3.9 months. No ≥ grade 4 adverse events were recorded; fatigue and constipation were the most common grade 1-3 adverse events occurring in 29% and 34% of patients, respectively. No other toxicity was observed in more than 10% of patients. PK analysis demonstrated a median steady-state plasma concentration of 21 μ g/mL, which is similar to the IC50 concentration identified for renal cancer cell lines in vitro. Conclusions: AS1411 has activity in RCC with minimal toxicity; PFS was comparable to that seen with active agents in the refractory setting. Further studies are needed to determine the optimal dosing and scheduling for this novel therapeutic. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Antisoma Antisoma