bluuebunny/crossref_metadata_2025 huggingface dataset:
Efficacy and safety of neoadjuvant paclitaxel, ifosfamide, and cisplatin (TIP) chemotherapy in locally advanced squamous cell cervical carcinoma followed by radical surgery: A single institution experience.
Authors: Scandurra Giuseppa , Scibilia Giuseppe , Banna Giuseppe Luigi , Lipari Helga Maria Alessandra , D'Agata Gabriella , Scollo Paolo
Published: March 2020

e16532

Background: The management of locally advanced squamous cell cervical carcinoma includes chemoradiotherapy or neoadjuvant cisplatin based chemotherapy followed by surgery, that may offer specific advantages a better potential activity. Porpouse: To evaluate efficacy and safety of TIP neoadjuvant chemoregimen in patiens affects by local advanced squamous cell cervical carcinoma. Methods: July 1997 - December 2011 were treated at our institution 165 patients with locally advanced squamous cell cervical carcinoma of whom 143 are evaluable. Regimen: Ifosfamide 5000 mg/mq ev day 1 iv in 24 h ; Mesna 5000 mg/mq ev day 1 iv in 24 h ; Paclitaxel 175 mg/mq ev day 2; Cisplatin 75 mg/mq ev day 2; every 3 weeks for a total of three courses. Tumor extension was assessed clinically and by abdominal MRI, PET WB and 3D ultrasound at baseline and after three courses.The operable patients after TIP chemoterapy underwent radical hysterectomy and pelvic lymphadenectomy. The median age 53 ( range 24-79 yrs), clinical FIGO stage Ib 2 2 pts(1%) , IIb 59 pts(41%), IIb bulky 68 pts (48%), III-IV 14 pts (10%), histological subtype SCC 138 pts (96%) and adenocarcinoma 5 pts ( 4%). Results: After neoadjuvant chemiotherapy 132 pts (92%) underwent surgery. Post-chemotherapy pathological response was pCR 25 pts (19%), PR1 16 pts (12%), PR2 80 pts (61%), SD 10 pts (7%), PD 1 pt (1%). Median numbers of courses of TIP administrated was 3 ( range 1-3). Treatments was delay or withdrawal in 22 pts ( 16%). Treament limiting toxicities were, Neutropenia 11 pts (52%), Anemia 10 pts (45%),Thrombocytopenia 7 pts (33 %), Renal failure 3 pts (14 %), Allergic reaction 3 pts (14%), Vomiting 3 pts (14%), Febrile neutropenia 2 pts (10%), Hypopotassiemia1 pt (5%), Atrial fibrillation 1pt( 5%), Pneumonia 1 pt (5%). Conclusions: In our experience neoadjuvant TIP was feasible, effective with 92% resection rate and active in an older and higher stage disease enriched series than reported in previous clinical trials.
Adjuvant image guided (IGRT) intensity-modulated Arc radiotherapy for vulvar cancer.
Authors: Mathiesen Hanne From , Banner-Voigt Marie Louise Vorndran Coeln , Lassen Soeren , Mirza Mansoor Raza
Published: March 2020

e16541

Background: A retrospective analysis to determine the efficacy and toxicity of PET-CT image guided intensity modulated arc radiotherapy (arctherapy) with concomitant weekly cisplatin as adjuvant treatment of vulvar cancer patients (pts) with high-risk of relapse after primary surgery. Methods: Pts were identified as high-risk of relapse after primary surgery (free-margins of vulvar tumor <8mm; positive sentinel node/nodes). Pts were treated with radiation (RT) plus weekly cisplatin. All pts were planed by PET-CT scan. Target volumes were delineated together with onc-radiologist. The decision to irradiate vulva and/or unilateral/bilateral nodes was made independently. Principal of one-plus nodal region was applied. 46-50,7Gys were delivered in 23-27 daily fractions by arctherapy. Results: 25 consecutive pts (median age 64 years) were treated during 01.09.2008-30.09.2012. In the initial period IMRT was used (4 pts). Vulva was treated in all pts; unilateral nodal RT in 8 pts and bilateral nodal RT in 17 pts. No grade ≥2 toxicities were recorded. 24 pts are relapse-free with a median follow-up of 14.8 months. 1 pt had early relapse with later fatal outcome. Conclusions: Image guided arctherapy is highly effective and well tolerated. Further experience and long-term data with this technique is to be attained.
A protocol with adjuvant chemotherapy (CT) and radiotherapy (RT) for endometrial cancer: Results.
Authors: Romeo Margarita , Capdevila Laia , Cros Sara , Tarrats Antoni , Takeuchi Maya , Torrent Juan Jose , Carballas Elvira , Sastre Josep Maria , Gomez Maria Carmen , Tuset Victoria , Tapia Gustavo , Balana Carmen
Published: March 2020

e16549

Background: The classic adjuvant treatment for high-risk endometrial cancer is RT. Several phase III trials explored the role of CT, as single treatment or added to RT sequentially (ST) or concurrently (CR), but design heterogeneity hampers conclusions. We report the results of a single-institution protocol with adjuvant CT + RT for advanced stages or type II histologies. Key points: (1) ST and CR permitted. (2) CT used pre-, post- and/or during RT: carboplatin AUC 5 + paclitaxel 175 mg/m2 (150 during RT) Q3W, 4-6 cycles (“carbotaxol”). (3) since 2010, cisplatin 50 mg/m2 was used for CR (on day 1 and 28 of RT). CR was preceded/followed by carbotaxol. Methods: All patients (PT) included in the protocol between 1/2005 and 9/2011 were retrospectively revised. Endpoints were survival and toxicity grade 3-4. Kaplan Meier and Fisher test were used. Conclusions: CR-carbotaxol showed a longer progression-free and overall survival than ST without reaching statistical significance (log rank, p= 0.14 and p=0.33). Median survivals with CR-cisplatin were not reached because of shorter follow-up. Statistical differences in toxicities were not found. In the CR-carbotaxol arm, 5 PT had grade 3-4 acute diarrhoea vs none in the others. [Table: see text]
Pregnancy following surgery and chemotherapy for ovarian germ cell tumors.
Authors: Murphy Karen , Alken Scheryll Paula , McCaffrey John , Carney Desmond , O Connor Miriam
Published: March 2020

e16550

Background: Malignant ovarian germ cell tumours(OGCT) are a rare disease, accounting for 2% of all malignant ovarian tumours diagnosed in Ireland between 1994 - 2010. They affect a younger population than epithelial ovarian cancer, with the highest number of cases in the second and third decade. In this report, we present a review of patients treated in a tertiary referral centre. Methods: We performed a retrospective review over a 26 year period in our institution. We examined clinical records, pathology, pharmacy and surgical databases to identify patients with ovarian germ cell tumours who were treated in our institution. Results: During the period 1986 – 2012, twenty patients were treated and followed at this institution for malignant ovarian germ cell tumor (OGCT). Eighteen patients are alive and well at a median follow up of 14.5 years (range 0.5 – 26). Nineteen patients received platinum based chemotherapy with a median number of four cycles (range 2 – 6) required to achieve complete remission. Twenty percent of patients had yolk sac histology; the next commonest were immature teratomas and mixed germ cell tumour (10 & 15% respectively). The commonest chemotherapy regimen used was BEP (bleomyocin, etoposide and cistplatin). Six patients (30%) underwent resection of residual disease post chemo revealing mature teratoma/necrotic tissue. During follow up, four patients had progressive or recurrent disease. Two patients at resection had mature teratomas found on histological examination. The remaining two patients (10%) had progressive disease and died within a short time period. In our patient population, nine of nine attempting pregnancy have been successful. There have been 12 pregnancies carried to term; mother and child in each case are well. At a median follow up of 14.5 years (range 0.5 – 26), there have been no second malignancies and no toxicities attributable to chemotherapy. Conclusions: We have shown that platinum based chemo in OGCT is associated with preservation of fertility in these young women. In our series there have been no adverse affects in women or their infants. Platinum based chemo highly successful in curing OGCT and this confirms that it is associated with preserved fertility in these young women.
Comparative effectiveness of treatments for recurrent ovarian cancer.
Authors: Bickell Nina A. , Deb Partha , Hayes Monica Prasad , Franco Rebeca , Howell Elizabeth A. , Wisnivesky Juan P. , Sun Ruirui , Egorova Natalia
Published: March 2020

e16551

Background: Traditionally, recurrent ovarian cancer has been treated with chemotherapy. However, increasingly, secondary cytoreductive surgery (SCS) is being performed. We undertook this study to compare survival between SCS vs chemotherapy vs both or neither to treat recurrent ovarian cancer. Methods: Using SEER-Medicare 1997-2007, we identified women age 66+ years with primary late stage epithelial ovarian cancer with fee-for-service Medicare treated with surgery and chemotherapy for their primary cancer who experienced a recurrence. We defined recurrent cancer using claims for chemotherapy, hospice or SCS following a 6 month treatment free window after primary treatment. Survival time is calculated from time of first recurrence. We conducted parametric and semi-parametric multivariate survival analyses to assess comparative treatment survival rates and factors affecting survival. We use propensity score weighting methods to obtain robust estimates of comparative effectiveness. To address the risk that a fraction of patients classified by our algorithms as non-recurrent are, indeed, recurrent, we use finite mixture models. Results: Of the 1,623 women with recurrent cancer, 72% received secondary chemotherapy while 15% receive both chemotherapy and surgery. <2% receive secondary surgery and 12% received hospice with no active treatment. Univariate analyses show that the mean survival time after first recurrence of ovarian cancer is 1,357 days. Multivariate survival models controlling for patient demographics, cancer type and comorbidities show that, compared to patients who received both surgery and chemotherapy, those who received only SCS (-569 days) as well as those who received only chemotherapy (-381 days) had significantly lower survival times. Survival time is negatively associated with black race and age at recurrence and positively associated with date of reoccurrence. Patients with greater comorbidities have significantly shorter survival times. Conclusions: Patients with recurrent ovarian cancer treated with both secondary surgery and chemotherapy survive longer than patients treated with either chemotherapy or surgery. Women who are Black, or older at time of recurrence have worse survival.
Weekly topotecan and biweekly bevacizumab in recurrent and progressive ovarian carcinoma: A single institution experience for third-line or greater treatment.
Authors: Grzankowski Kassondra S , Lele Shashikant B. , Pietkiewicz John
Published: March 2020

e16553

Background: The toxicity and efficacy of combined weekly topotecan and weekly bevacizumab in women with recurrent and progressive ovarian cancer. Methods: Reviewed data-base from 1/2003-present (1/2013) identified 15 patients who were treated with topotecan 4mg/m2 on days 1, 8, and 15 and bevacizumab 10mg/kg on days 1 and 15 of a 28-day cycle until progressive disease or excessive toxicity warranted discontinuation. The primary endpoint was progression-free survival. Results: Patients (n = 15) received a median of 4 treatment cycles. Mean number of previous chemotherapy regimens was 5 (range 2-9). Toxicity was generally mild, with neutropenia (20%), gastrointestinal toxicity (20%), pain (26%), anemia requiring transfusion (6%) being the most common adverse events. Two patients required dose adjustment secondary to neutropenia. Patients treated with 5 or more prior regimens had more adverse events, 66% vs. 33%, respectively. No febrile neutropenia or treatment-related deaths occurred. Median PFS and OS were 5.6 months and 5.9 months with 6 (40%) patients progression-free for ≥5 months. Two (13%) patients had complete response, 9 (60%) had stable disease or partial response and were still receiving the above mentioned treatment, and 4 (27%) had progressive disease. Conclusions: Treatment of recurrent and progressive ovarian cancer with weekly Topotecan and biweekly Bevacizumab demonstrates a viable efficacy with acceptable toxicity profile in women with previous multiple lines of treatment; as this becomes a more widely used regimen further investigation will be needed to determine early use of this well tolerated chemotherapy.
Treatment of recurrent Langerhans cell histiocytosis of the vulva with lenalidomide.
Authors: Ibrahim Ibrahim Fuad , Naina Harris V. K.
Published: March 2020

e16555

Background: Langerhans cell histiocytosis (LCH) of the female genital tract is an extremely rare disease. We report a 14 year follow up of a patient with LCH successfully treated with lenalidomide in the relapsed setting. Methods: N/A. Results: A 43 year old Ethiopian woman initially presented to another institution with a nodular lesion on her left vulva with biopsy consistent with LCH. Metastatic workup at the time did not reveal evidence of distant disease. The patient was initially treated with radiotherapy to the vulva and 2 years later she was diagnosed with recurrent disease in the vulva and underwent a wide local excision. Six months afterwards she developed a lesion on her right labium majus consistent with disease recurrence. She was treated with radiotherapy again and underwent a wide radical vulvar excision. She recurred only 3 months later and was started on salvage therapy with thalidomide, 3 years after the initial diagnosis. Within 2 months of starting thalidomide therapy, the patient experienced resolution of vulvar lesions and symptoms. She remained symptom free for 8 years while on thalidomide but then presented to our institution with a new central vulvar lesion after being off therapy for 4 months. Vulvar biopsy confirmed the presence of LCH. She was subsequently restarted on thalidomide and achieved symptom control for an additional 18 months before developing worsening pain and neuropathy associated with therapy. Imaging revealed no evidence of metastatic disease. We then started lenalidomide therapy at dose of 10 mg daily for 21 days in a 28 day cycle and subsequently increased the dose to 25 mg daily continuously. She achieved marked improvement in vulvar symptoms within a month of initiation of lenalidomide. She has tolerated therapy well with no neuropathy or cytopenias. Conclusions: Primary vulvar LCH is a rare disease with no standard therapies. Thalidomide has been described in the literature as an effective treatment option. We describe the use of lenalidomide as an alternative and well tolerated therapy in the relapsed setting. Further investigation is required to determine whether lenalidomide is a viable first line therapy for this rare disease.
Significance of panendoscopy and CT in the follow-up and management of squamous cell carcinoma of the head and neck: A retrospective clinical assessment.
Authors: Muenscher Adrian , Sehner Susanne , Taleh Jegane , Tribius Silke , Dalchow Carsten , Moeckelmann Nicolaus , Gulati Amit , Clauditz Till , Knecht Rainald
Published: March 2020

e17003

Background: Treatment of patients with head and neck squamous cell carcinomas (HNSCC) require an evidence-based multidisciplinary approach which varies from medical centres. Panendoscopy has been traditionally used as a routine screening examination tool. We discuss and compare its clinical effectiveness, safety and predictive value in patients with computed tomography (CT) scans in a routine outpatient follow up. Methods: Between 2004-2007, in a retrospective study (204 patients; male:156 (76.5%); female:48 (23.5%))with head and neck cancer, fulfilled all inclusion and exclusion criteria were evaluated at the University Medical Center Hamburg-Eppendorf, Germany. Follow-ups were performed every 2 to 3 months for the first 3 years and every 6 month for the following 2 years. UICC-TNM staging system divided patients into seven categories. Results: The mean age of patients was (male: 59.2±9.3 years; female: 59.5±10.2 years), the highest incidence rate was recorded in the 51 to 60 age group (n = 77). There was a male predominance, with a male/female ratio of 3:1. In comparing normal versus abnormal CT a 12-fold higher frequency of recurrence (odds ratio [OR]; 95% CI: 3.99, 37.51; p<0.001) was interpreted.Additionally, patient anamnesis (OR: 3.33; 95% CI: 1.57, 7.07; p=0.002), clinical investigation (OR: 5.85; 95% CI: 3.01,11.36; p<0.001) and recurrence pattern (OR: 4.82; 95% CI: 2.26,10.32; p<0.001) was observed. Conclusions: In staging / follow-up HNSCC patients, CT-diagnostics also provided similar levels of accuracy as panendoscopy. Panendoscopy in patients with HNSCC was avoided (169 out of 364) when the diagnostic parameters remained satisfactory. Higher patient satisfaction, structural information at a high spatial resolution and comfort was noted in the CT group, indicating a gradual move towards CT diagnostics. For safety-related reasons in particular, we recommend panendoscopy for histological evaluation i.e.in predicting cancer recurrence and progression.
Pretreatment characteristics and early indicators of long-term efficacy of cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (rmSCCHN).
Authors: Keilholz Ulrich , Knoedler Maren , Redlich Ines , Gauler Thomas Christoph
Published: March 2020

e17015

Background: Cetuximab has established activity in rmSCCHN as a single agent as well as in conjunction with chemotherapy. Combination treatment protocols lead to significant toxicity. It would be of interest to identify pretreatment characteristics and early indicators of long-term cetuximab efficac. Methods: rmSCCHN patients were analysed, who participated in trials of chemotherapy plus cetuximab, followed by cetuximab maintenance. Patients were stratified into two groups of long term exposure (LTE) and short term exposure (STE) of cetuximab using 6 months as cut-off. Factors considered for analysis included age, sex, performance status, smoking behavior, primary tumor site, time from primary to treatment for rm-disease, number of chemotherapy cycles received, response, toxicity, and reason for treatment discontinuation. Results: In 2 institutions, 61 patients were enrolled in 5 clinical trials between 2008 and 2011. Cetuximab was administered in standard dose and schedule until disease progression or unacceptable toxicity. 27 patients received cetuximab <6 mo (STE, median 1.5 mo) and 34 >6 mo (LTE, median 9 mo). Patients with LTE as compared to STE only differed in 2 characteristics: oral/oropharyngeal primary (56% vs. 41%) and median chemotherapy cycles received (6 vs. 2). Comparing LTE to STE, treatment discontinuation during the chemotherapy phase was due to toxicity in 14 vs. 37% or death in 4 vs. 15%. Median OS in LTE vs. STE was 18 vs. 4 mo. Conclusions: LTE was associated with a huge improvement of OS. Toxicity of chemotherapy was a relevant factor for early discontinuation of combination treatments, limiting the overall efficacy of cetuximab. Results may be improved by further intensification of the already implemented proactive toxicity management, but also by development of less toxic chemotherapy schedules.
Downregulation of Sprouty2 protein in human squamous cell carcinoma of the head and neck and suppression of cell proliferation in vitro.
Authors: Feng Yin-Hsun
Published: March 2020

e17018

Background: Sprouty2 is known for its tumor-suppressing effect in various human malignant diseases. In head and neck squamous cell carcinoma (HNSCC), the role of sprouty2 in tumorigenesis and clinical implication is still unknown. Methods: Quantitative analysis of mRNA expression of sprouty2 was performed on frozen tumor samples from 42 patients with HNSCC and 19 oral verrucous hyperplasia (OVH). The expression of sprouty2 RNA was determined as the ratio of tested tumor sample and paired counterpart of normal mucosa , Sprouty2 expression and signaling in HNSCC cell lines were assessed by immunoblotting. In vitro proliferation was evaluated in HNSCC cell lines in response to enhanced expression of sprouty2 protein. Inhibition of cell proliferation by tyrosine kinase inhibitor, sorafenib, after modulation by expression of sprouty2 was measured by inhibition concentration. Results: Downregulation of sprouty2 expression was demonstrated in 79% of HNSCC samples compared with paired samples of normal mucosa, and in 58% of OVH samples compared with paired samples of normal mucosa. Low expression of sprouty2 was associated with invasiveness of huam HNSCC (p=0.03). Enhanced expression of sprouty2 protein suppressed the growth of HNSCC cells and signaling of the phosphorylated AKT pathway. After transfection of sprouty2 plasmid, HNSCC cells were more sensitive to sorafenib, a tyrosine kinase inhibitor of Raf and vascular endothelial growth factor receptor. Conclusions: Our data show that sprouty2 expression is down-regulated and behaves as a tumor suppressor in HNSCC. Sprouty2 expression in tumor cells enhances sensitivity to sorafenib.
Cetuximab, fluorouracil (5-FU), cisplatin, and docetaxel as first-line treatment in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Interim results of a randomized phase II clinical trial (CeFCiD).
Authors: Knoedler Maren , Dietz Andreas , Gauler Thomas Christoph , Gruenwald Viktor , Stoehlmacher Jan , Knipping Stephan , Guntinas-Lichius Orlando , Frickhofen Norbert , Schroeder Michael , Maschmeyer Georg , Rethwisch Volker , Haxel Boris , Keilholz Ulrich
Published: March 2020

e17021

Background: This study investigates efficacy and toxicity of docetaxel added to cetuximab, cisplatin and 5-FU for patients with R/M SCCHN. We here report a planned second interim analysis to compare response rates between arms in order to decide on continuing to full accrual. Methods: Inclusion criteria were: stage III/IV R/M SCCHN and ECOG 0-1. Patients were randomized to arm A: cetuximab (standard dose) plus a maximum of 6 cycles of docetaxel (40 mg/m², day 1+8), cisplatin (40 mg/m², day 1+8) and 5-FU (2000 mg/m², day 1+8) or to arm B: cetuximab (standard dose), cisplatin (100 mg/m², day 1) and 5-FU (1000 mg/m², day 1-4). Treatment was administered until progression or intolerability. The endpoint of this analysis was RR. Results: A first interim analysis for toxicity after treatment of 20 patients per arm revealed more hematologic and gastrointestinal grade III/IV toxicities in the experimental arm. Therefore dose reductions of cisplatin from 40 to 30 mg/m² and 5-FU from 2,000 to 1,000 mg/m² had been introduced. A secondary toxicity analysis with 40 patients per arm observed reduced treatment related toxicities. Currently 100 patients could be assessed for response: arm A: 82 % male, median age 58 years, arm B: 82 % male, median age 60 years. Best overall RR was 41 % (3 CR, 18 PR) in arm A compared to 45 % (4 CR, 19 PR) in arm B. The DCR was 75 % in arm A and 80 % in arm B. Conclusions: After introducing dose reductions toxicity is manageable. Comparable response rates were seen in both arms. CeFCiD continues per protocol for evaluation of the primary endpoint PFS. Enrollment is estimated to be completed in Aug 2013. Clinical trial information: CeFCiD-1108.
Comparitive study of quality of life in locally advanced head and neck cancers with concurrent chemoradiotherpy with three weekly cisplatin versus weekly cisplatin regimen.
Authors: Adavikolanu Kesava Ramgopal , Malik Monica , Lachi Pavankumar , Kothwal Syedakram , M Deepajoseph , Syed Fayaz ahmed , Pamidighantam Suresh , K.V Jagannathraonaidu
Published: March 2020

e17028

Background: Concurrent chemoradiotherapy with three weekly cisplatin is the standard of care for organ preservation in locally advanced head and neck cancers. Quality of life (QoL) is vital in this strategy and this study aims to compare QoL in patients of locally advanced head and neck cancers treated with concurrent chemoradiation with either three weekly or weekly cisplatin regimen. Methods: Between January 2011 and May 2012, 30 patients of locally advanced head and neck cancer were divided into two arms each consisting of 15 patients. All patients received conformal radiotherapy (RT) on linear accelerator to a total dose of 70 Gy, 2 Gy per fraction over 35 fractions. Patients in Arm A received concurrent chemotherapy with Cisplatin 100mg/m2 given on day1,22,43. Patients in Arm B received concurrent chemotherapy with Cisplatin 40 mg/m2given weekly for seven weeks. QoL was assessed using EORTC QLQ-C30 and QLQ-H&N35 questionnaires at baseline, completion of RT and at one and two months following completion of treatment. The collected data was analyzed using standard statistical software package (SPSS version 20.0). Results: Median age in Arm A and Arm B were 45 years (range 23-67years) and 48 years (range 36-71) respectively. All patients completed the planned RT, 73% of patients in Arm A and 93% of patients in Arm B received the planned dose of chemotherapy. Compliance with completion of QoL questionnaires was high in both arms. QoL scores decreased during chemoradiotherapy in both arms, and the scores were better in Arm B without statistical significance. The QoL scores reached baseline earlier in the Arm B compared to Arm A for most of the function scales and symptom scales at second month follow up. There was no statistical difference between the two arms for most of the parameters, except for symptom scales of pain (p=0.029) at 1st month follow-up and swallowing (p=0.023) at 2ndmonth follow-up favouring Arm B. Conclusions: Chemoradiotherapy with weekly cisplatin 40mg/m2 with its better compliance and favourable quality of life can serve as an alternative for the conventional three weekly cisplatin regimen.
Induction chemotherapy (ICh) followed by concurrent chemoradiotherapy (ChR) in locally advanced squamous cell carcinoma of head and neck (SCCHN): Experience in a Mexican institute.
Authors: Avitia Miguel Angel Alvarez , Ponce Jose Luis Aguilar , Lara Gisell Anaid , Molina Violeta Moreno , De La Garza Jaime G. , Granados-Garcia Martin , M Juan Cruz , Mendoza Andres Moran , Ruiz Abraham
Published: March 2020

e17031

Background: ICh has taken an important role in the treatment of locally advanced disease, but it has not been recognized in which patients (pts) may be the best option ICh followed by ChR or just ChR. We present our experience with ICh followed by ChR regimen in the National Cancer Institute of Mexico (INCan). Methods: We identified 69 patients (pts) diagnosed with locally and/or regionally advanced non-metastatic squamous cell cancer of head and neck, who were attended at the INCan from 2008-2012, in whom, the original treatment was ICh with two cycles of Paclitaxel (P), cisplatin (C) and 5Fluorouracil (5FU) scheme, followed by concurrent ChR with C. But only 35 pts of the original group accomplished the treatment. Results: 13 pts were women (37%) and 22 were men (63%).The median age at diagnosis was 59 years old. In stages III (28%), IVa (46%), and IVb (26%); AJCC, 2002. The subsites per pts. studied were: oral cavity 9 (25.7%), larynx 9 (25.7%), hypopharynx 7 (20%), paranasal sinuses 7 (20%) and oropharynx 3 (8.6%). The rate response was observed in 83%: complete objective rate response (CR) in13 pts (37%), partial response rate in 16 pts (46%) and progression rate in 6 pts. (17%). The mean survival was of 18.3 months (mth) (CI-95: 0.32-0.68).Median survival was not achieved in pts with CR with a median follow up of 2 yrs, pts with PR had a median survival of 15 mth (CI-95: 0.27-0.75) and the median progression was 11 mth (CI-95: 0.11-0.80). We have not got any CR with ICh only, but 13 patients obtained CR at the end of the ChR. Neither age, sex nor subsites were crucial to the clinical response. Conclusions: Our results cannot distinguish patients who might benefit from ICH. In the intention-to-treat population, more than a half of pts did not complete the proposed scheme. Recently, we reported a study using an alternative scheme: Cisplatin and gemcitabine concurrent with radiotherapy to treat pts with advanced SCCHN, and we found that this scheme of treatment is effective and well tolerated, with a 5 yr progression-free survival rate of 27.8 (CI-95: 0–61.5). Yet further studies are needed to compare ICh followed by RCh vs RCh to assess what the best treatment may be.
Methotrexate and cetuximab for metastatic advanced head and neck squamous cell carcinoma.
Authors: Atassi Bassel , Yoo George H. , Robinette Natasha , Sibai Khaled , Sukari Ammar
Published: March 2020

e17033

Background: After the failure of first-line palliative chemotherapy in recurrent non-resectable or metastatic head and neck squamous-cell carcinoma (HNSCC), there is no standard of care second-line treatment that is proven to improve quality of life or prolong survival. Both methotrexate and cetuximab has shown a single-agent activity in advanced HNSCC. We are presenting our institutional experience in using unique combination chemotherapy with methotrexate plus cetuximab (MC). Methods: Retrospectively, single institution’s charts were reviewed from 2004-2010, all patients have documented recurrent non-resectable or metastatic HNSCC. After failing at least one line of palliative chemotherapy, patients received weekly IV methotrexate 25 mg/m2 plus IV cetuximab 400 mg/m2 loading dose at week one followed by 250 mg/m2 maintenance dose weekly. Each cycle is 4 weeks treatments. Patients who completed at least 2 cycles were included in the study. Patients can receive MC as first line if they have poor performance status. Treatment was continued until progression. Results: Total of 34 patients were included in the study, 26 male and 8 female, 18 African American and 16 Caucasian. Median patient age was 60 years old. 18, 6 and 6 patients received MC as second, third and fourth line therapy, respectively. 4 patients received MC as first line because there were not candidates for more aggressive chemotherapeutic regimens. The average received number of weekly treatments was 25 (8-69) and average number of cycles was 6 (2-17). Prior chemotherapy regimens include taxanes, platinum, 5-flurouracil, and gemcitabin. Median progression free survival was 4.9 months and overall survival was 10.7 months. Overall survival based on race was 9.9 months for Caucasians and 10.7 months for African Americans (P=0.0391). Grade I and II skin rash was observed in 41% of patients, no grade III/IV toxicities were noticed. Conclusions: Methotrexate plus cetuximab is a well tolerated regimen with a significant survival benefit. Prospective studies are warranted in order to evaluate this regimen as a second line palliative therapy for patients with advanced non-curable head and neck squamous cell carcinoma.
“Stop smoking!”: Do we say it enough?
Authors: Reifer Hildebrand Jessica Ann , Sastry Sangeeta , Adams Ashley
Published: March 2020

e17500

Background: There are clear benefits of smoking cessation after the diagnosis of Bronchogenic Carcinoma (BC). Patients who quit smoking after the diagnosis of BC report lower levels of pain and are less likely to develop a second primary tumor when compared to patients who continue to smoke after they are diagnosed. Persistent smoking is also associated with poor performance status and survival outcomes. Evidence suggests that smokers are more likely to quit if they are counseled by their physicians. Yet, there may be a prevailing belief among physicians that treating tobacco dependence is futile in this population. The purpose of this study was to investigate whether physicians addressed smoking cessation with patients who were diagnosed with BC. Methods: A retrospective chart review of patients who were diagnosed with BC was conducted at a community medical center between 2008 and 2010, using the hospital’s cancer registry. Demographic information including age, race, sex, AJCC stage, and smoking status at the time of diagnosis was collected. Evidence of tobacco cessation counseling was sought through billing codes, physician notes, and orders surrounding the time of diagnosis. Results: A total of 948 patients were diagnosed with lung cancer between 2008 and 2010. 438 were current smokers at diagnosis, 422 were former smokers, and 88 had never smoked. Of the 438 smokers, only 36% were counseled on smoking cessation. On average, each patient encountered 3 different physicians in both the inpatient and outpatient settings. Of note, Stage I patients were 1.7 times more likely to be counseled than those with Stage IV disease (p=0.017). There was no significant difference between the counseled group and the non counseled group in regards to age, race, or sex. Conclusions: In spite of evidence that smoking cessation is beneficial even after the diagnosis of BC, physicians are not counseling their patients sufficiently. Reasons physicians may fail to counsel include: an inability to effectively assess tobacco dependence, competing concerns during patient encounters, and reduced awareness of current quality measures. With the implementation of quality improvement programs, we suspect that smoking cessation counseling for patients with BC will improve in the community setting.
Cost comparison and economic implications of commonly used originator and generic chemotherapy drugs in India.
Authors: Lopes Gilberto , Kulkarni Hrishikesh , Bele Vivek
Published: March 2020

e17505

Background: Generic substitution may lead to increased access to cancer drugs. Little data have been published on cost savings in emerging markets. Methods: Estimate of cost and savings per cycle, per patient, and for India with generic drugs. Cost of paclitaxel, docetaxel, gemcitabine, irinotecan and oxaliplatin was obtained for originator branded and generic versions from a distributor in India. Costs are depicted in 2012 Rupees. Utilization was based on a BSA of 1.7, standard doses, expected lenght of treatment for common oncology indications and incidence data from GLOBOCAN. Results: Generic drugs cost from 8.9% to 36% of their equivalent branded originator drug, resulting in cost-savings of approximately INR 11,000 to 90,000 [US$ 200-1,600] per each drug per cycle; and approximately INR 50,000 to 240,000 [US$ 900-4,300] per patient treated. Overall, potential yearly savings for health systems in India were nearly INR 47 billion [US$ 843 million]. Conclusions: Generic substitution for commonly used chemotherapy agents has an enormous potential to generate significant cost-savings and increase access to cancer treatments in India and other low and middle income countries. [Table: see text]
Patients with schizophrenia and breast cancer: Adjuvant radiation treatment.
Authors: Davies Lauren , Abdullah Kashif , Janardhan Radhakrishna , Hwang Mark , Farasatpour Michael , Margenthaler Julie A. , Virgo Katherine S. , Johnson Frank E.
Published: March 2020

e17506

Background: Schizophrenia affects about 1% of subjects in all populations studied so far. It impairs medical care delivery. We sought to evaluate how patients with schizophrenia who are later diagnosed with breast carcinoma fare when adjuvant radiation therapy (ART) is indicated. Methods: We searched the Patient Treatment File (PTF) of the Department of Veterans Affairs (DVA) to identify subjects with schizophrenia who later developed breast carcinoma and were treated in DVA Medical Centers (DVAMCs) from 1999 - 2005. Chart-based clinical data from the DVAMCs where the subjects had been treated supplemented PTF data. Results: 42 patients had preexisting schizophrenia, later developed breast carcinoma, and were candidates for ART. There were 31 women (74%) and 11 men (26%). 27 of the 42 study subjects had records specifying TNM stage; 18 of the 27 (67%) had TNM stages III-IV. 31 subjects had records about compliance with indicated medical therapies; 24 (77%) had previously been non-compliant. 39 subjects had records regarding therapy delay; 20 (51%) had previously delayed medically indicated therapy. Of the 42 subjects who were candidates for ART based on TNM stage, we found data about the decision to recommend ART in 37; only 23 (26%) were offered ART and 3 of those 23 (26%) refused it. Of the 6 subjects who refused ART, 4 had been non-compliant with previous medically indicated care, 3 had delayed initial cancer treatment, 4 had documented suicidal ideation, and 2 had documented homicidal ideation before being offered ART. Conclusions: Subjects with schizophrenia and breast carcinoma often do not understand their illnesses well. They often do not comply with recommended standard therapies such as ART. Treatments that rely on ART are likely to be met with non-compliance. A history of non-compliance appears to be a predictor of non-compliance with ART. Our results should be of interest to caregivers because we describe ways to avoid suboptimal ART in patients with breast carcinoma. Breast-conserving multi-modality treatment with ART is frequently not appropriate; radical surgery is often preferable.
Characteristics of clinical trials for adolescent and young adult (AYA) cancer patients (pts) in Ontario.
Authors: Kwong Wilson , Fraser Graeme A , Barr Ronald , Tu Dongsheng , Meyer Ralph M.
Published: March 2020

e17525

Background: Outcomes of pediatric and adult cancer pts have improved more than outcomes of AYA pts. Reduced access of AYA pts to clinical trials may partially account for this. Methods: The 10 cancers of highest annual incidence for pts ages 15-29 were identified using the 2005-09 SEER data base and searched on ClinicalTrials.gov (2012/OCT/27) using restriction terms “recruiting”, “intervention studies”, “Canada-Ontario”, and “Adult (18-65)”. Among trials identified, variables compared were sponsor (industry; not industry), intent (curative; palliative; other), endpoints (survival; disease control-adverse event; other), previous therapy (none; other), age (max < 29; max>29 but <50; max>50), intervention (drug; RT+/-drug; other) and randomized design (yes; no). Comparisons used a 2-tailed Fisher’s exact test. Results: We identified 139 trials, including (incidence rank order in bracket): breast-41 (8), non Hodgkin’s lymphoma-36 (4), CNS-30 (6) and acute lymphoblastic leukemia (ALL)-21[10]. There were 45 trials available for the other 6 indications; some trials permitted multiple indications. Most common features were non-industry sponsorship (58%), palliative intent (65%), disease control-adverse event primary endpoint (82%), not restricted to 1st line therapy (76%), max age>50 (69%), drug-only intervention (78%) and non-randomized design (56%). Among all trials, those with an age restriction did not significantly differ from trials with an age maximum of >50. Industry sponsorship was associated with fewer non-drug-only trials (2% vs. 36%; p<0.0001), curative trials (12% vs. 41%; p=0.0002) and age-restricted trials (10% vs. 48%; p<0.0001). CNS and ALL trials were more likely to restrict age eligibility (60% vs. 13%; p<0.0001 for CNS; 52% vs. 18%; p<0.0001 for ALL) and have non-industry sponsorship (90% vs. 49%; p<0.0001 for CNS; 76% vs. 24%; p=0.09 for ALL). Conclusions: Availability of clinical trials for Ontario AYA pts is very heterogeneous and no correlation is seen between AYA cancer-type incidence and number of trials. While CNS cancers and ALL appear unique, access and characteristics of trials for other AYA pts appear to relate to determinants associated with older patients.
Cancer Care Ontario’s lung disease pathway initiative: Building resources for lung cancer quality care.
Authors: Evans William K. , Ung Yee , Chyjek Anna , Gollnow Angelika , Sawka Carol Anne
Published: March 2020

e17531

Background: Cancer Care Ontario (CCO) is the provincial agency mandated to improve the quality of cancer care in Ontario. CCO has driven quality improvement (QI) on a programmatic basis but in 2008, introduced Disease Pathway Management (DPM) as an additional QI approach. The lung cancer (LC DPM) began in 2009 as a two-year, phased initiative. Methods: The LC DPM team, consisting of clinicians, patients and system stakeholders, was organized into five groups and focused on aspects of the patient journey from diagnosis to end-of-life care, guided by draft pathway maps of the ideal state. 17 improvement concepts were identified of which 8 were selected for detailed development at a provincial consensus conference and validated as LC DPM’s Priorities for Action. 14 regional road shows presented region-specific performance and quality data to practitioners involved in LC patient care to promote ideas for improvement. Funding was provided to support both provincial and regional initiatives that addressed identified gaps. Results: Key outputs of the LC DPM initiative were: establishment of lung diagnostic assessment programs in 14 regions; completion of diagnostic and treatment pathways for NSCLC and SCLC which were grounded in evidence; 10 improvement projects on various stages of the cancer continuum; and 6 one-year Dyspnea Management Pilot Projects. For the dyspnea projects, each funded centre used different approaches and evaluated impacts on patient symptom burden, measured by Edmonton Symptom Assessment System (ESAS), patient satisfaction and quality of life. The learnings from each project have been summarized and will be shared with all regional cancer programs to facilitate knowledge transfer. Tools to support the patient experience include a LC Patient Pathway Map (PPM) and a document, Understanding Lung Cancer. The physician and patient pathways and related materials are available on CCO's website at https://www.cancercare.on.ca Conclusions: LC DPM has proven an effective strategy to accomplish system changes across a large geography that impact the quality of LC care, processes and patient experience. Indicator development and performance management will be used to sustain the gains achieved.
Access to colorectal cancer screening and treatment: Rural-urban disparity in availability of gastroenterologists, surgeons, and oncologists.
Authors: Aboagye Jonathan K , Kaiser Heather E , Hayanga Jeremiah William
Published: March 2020

e17534

Background: Although early detection of colorectal cancer using colonoscopy and its treatment can improve outcomes, geographic proximity may influence access to these services. We sought to examine disparities that may exist in colon cancer screening and treatment by comparing the distribution of providers for these services in rural and urban counties in the United States (US). Methods: A retrospective analysis was performed using the Health Resources and Services Administration’s Area Resource File 2009 data. Counties in the US were categorized into “rural” or “urban” using rural-urban continuum codes. The proportion of gastroenterologists, general surgeons and radiation oncologists per 100,000 people in a county was estimated. Multivariate linear regression analysis adjusting for socioeconomic variables was used to estimate the differences in proportions of gastroenterologists, general surgeons and radiation oncologists within these geographic areas. Results: A total of 3220 counties were identified comprising 1,807 “rural” and 1,413 “urban” counties. An unadjusted analysis showed an increased number of gastroenterologists, general surgeons and radiation oncologists per 100,000 of the population in urban counties as compared to rural counties. A multivariable analysis revealed 1.55 [95%CI (1.33-1.77), P<0.0001] more GI specialists, 2.03 [95% CI (1.31-2.76), p<0.0001] more general surgeons and 0.69 [95%CI (0.6-0.78), p<0.0001] more radiation oncologists per 100,000 people living in “urban” compared to “rural “counties. Conclusions: A rural-urban disparity exists in the density of gastroenterologists, general surgeons and radiation oncologists who traditionally provide colorectal cancer screening services or treatment. This might serve to affect access to these services and negatively influence outcomes for colorectal cancer in rural areas.
Utilization of prescription-assistance program for medically uninsured cancer patients: A case study of a public hospital experience in New York state.
Authors: Gao Limin , Joseph Jivin , Levy-Santoro Marcelle , Gotlieb Vladimir , Multz Alan S.
Published: March 2020

e17537

Background: With the advances in early detection, prevention, and treatment of some cancers, mortality rates in the United States have been consistently falling. However, with these successes have come substantial increases in the cost of cancer care. Antineoplastics are the leading therapeutic classes in hospital drug expenditures. Lack of insurance is associated with lower rates of cancer screening, later stage at diagnosis, and increased cancer mortality. Prescription assistance programs (PAPs) are offered by pharmaceutical manufacturers to provide medications at no out-of-pocket cost to medically indigent patients. To assist the Cancer Care Center at NUMC with drug costs for chemotherapies and maintain the quality care for patients, the Pharmacy department instituted a Patient Assistance Program (PAP) to obtain medication from the drug companies at no cost. NUMC is a “safety net” teaching hospital in suburban New York. It serves mostly an indigent population and is a Level 1 Trauma Center with over 77,000 emergency department visits per year. Methods: We followed all patients requiring assistance with chemotherapy who enrolled in our PAPs from January 1, 2011 to December 31, 2012. Individuals potentially eligible for PAPs were identified by Oncologists and by the pharmacy department. Medications included both oral and parenteral chemotherapy drugs and antiemetics. Results: The program served 341 patients in 2011 and 579 patients in 2012. The total number of visits in the clinic over 24 months was 9,405. The total cost savings of the medications was $908,944.11 in 2011 and $1,715,538.37 in 2012. Conclusions: PAPs provide a valuable safety net to ensure that cancer patients without insurance receive needed prescription medications. The rising cost of health care and the high proportion of indigent patients have financially burdened the hospital. A pharmacy-based program to procure free medications for uninsured cancer outpatients has helped to defray the Cancer Care Center’s expense of providing care at NUMC, increased patients’ compliance with chemo-protocols and allowed many patients to receive the treatment they otherwise would not be able to afford.