Patient-Reported Continuity of Care and Functional Safety Concerns After Inpatient Cancer Rehabilitation.

BACKGROUND: Patients with cancer have been noted to have inadequate continuity of care after discharge from hospital. We sought to assess patient-reported continuity of care and functional safety concerns after acute inpatient rehabilitation. METHODS: This was a prospective study that used cross-sectional surveys at a National Cancer Institute Comprehensive Cancer Center. All patients who were admitted to acute inpatient rehabilitation from September 5, 2018, to February 7, 2020, met the inclusion criteria, and completed two surveys (assessing continuity of care and functional safety concerns) upon discharge and 1 month after discharge were included in the study. RESULTS: A total of 198 patients completed the study, and no major concerns were reported by the patients. The greatest concern was a lack of adequate communication management among different providers, reported by only 10 (5.0%) patients. The combined fall and near-fall rate within 1 month after discharge was (25/198) 13%. Brain metastasis, a comorbidity of depression, and a history of falls were significantly associated with a higher risk of falls or near falls within 1 month after discharge. CONCLUSION: Although overall patients with cancer reported adequate continuity of care and feeling safe to function at home after acute inpatient rehabilitation, it is important to be aware that fall or near-fall events within 1 month after acute inpatient rehabilitation are associated with brain metastasis, comorbidity of depression, and a history of falls. Thus, patients with these risk factors may benefit from including more focused fall prevention education and interventions. IMPLICATIONS FOR PRACTICE: Patients with cancer often have extensive problems that require care from multiple health care providers simultaneously, and a high level of coordination is needed for adequate transition of care from the inpatient to the outpatient setting. This transition of care period is prone to inadequate continuity of care and, for older adults, a particular risk for falls. Assessment for risk of fall is also an important factor to consider when evaluating patients to continue oncology treatments. There is a gap in knowledge regarding patient-reported continuity of care and functional safety concerns after acute inpatient cancer rehabilitation.

Frequency of Sarcopenia, Sarcopenic Obesity, and Changes in Physical Function in Surgical Oncology Patients Referred for Prehabilitation.

PURPOSE: Sarcopenia and suboptimal performance status are associated with postoperative complications and morbidity in cancer patients. Prehabilitation has emerged as an approach to improve fitness and muscle strength in patients preoperatively. We sought to describe the frequency of sarcopenia and sarcopenic obesity (SO) in a cohort of cancer patients referred for prehabilitation and the association between body composition and physical function. METHODS: In this retrospective review of 99 consecutive cancer patients referred for prehabilitation prior to intended oncologic surgery, prehabilitation included physical medicine and rehabilitation (PM&R) physician evaluation of function and physical therapy for individualized home-based exercise. Sarcopenic A was defined using sex-adjusted norms of skeletal muscle (SKM), measured using the sliceOmatic software (TomoVision, 2012) on computed tomography images at baseline. Sarcopenic B was defined by abnormal SKM and physical function. SO was defined as sarcopenia with BMI ≥ 25. Six-minute walk test (6MWT), 5 times sit-to-stand (5×STS), and grip strength were obtained at consultation (baseline) and at preoperative follow-up (if available). RESULTS: Forty-nine patients (49%) were Sarcopenic A, 28 (28%) SO, and 38 (38%) Sarcopenic B. Age was negatively correlated with SKM (P = .0436). There were no significant associations between Sarcopenic A/B or SO with baseline or changes in physical function. Assessed by sex, Sarcopenic A females had low 5×STS (P = .04) and Sarcopenic B females had low GS (P = .037). Sarcopenic B males had low preoperative GS (P = .026). 6MWT and grip strength at baseline were lower than age- and sex-related norms (both P < .001). Preoperatively, 6MWT distance and 5×STS time improved (both P < .001). Functional improvement in the sarcopenic and nonsarcopenic patients did not differ according to sex. CONCLUSIONS: In this cohort of prehabilitation surgical oncology patients, frequencies of sarcopenia and SO were high, and baseline physical function was abnormal but improved significantly regardless of body composition. These findings suggest that patients have considerable prehabilitation needs and are capable of improving with comprehensive care.

Association between Spirituality, Religiosity, Spiritual Pain, Symptom Distress, and Quality of Life among Latin American Patients with Advanced Cancer: A Multicenter Study.

Objectives: The purpose of this multicenter study was to characterize the association between spirituality, religiosity, spiritual pain, symptom distress, coping, and quality of life (QOL) among Latin American advanced cancer patients. Methods: Three hundred twenty-five advanced cancer patients from palliative care clinics in Chile, Guatemala, and the United States completed validated assessments: Faith, Importance and Influence, Community, and Address (FICA) (spirituality/religiosity), Edmonton Symptom Assessment Scale-Financial/Spiritual (ESAS-FS), including spiritual pain, Penn State Worry Questionnaire-Abbreviated (PSWQ-A), Center for Epidemiologic Studies Depression Scale (CES-D), Brief-coping strategies (COPE) and Brief religious coping (RCOPE) and RCOPE, respectively, and Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being, Expanded version (FACIT-Sp-Ex). Results: Median age: 58 years (range: 19-85); 60% female; and 62% Catholic and 30% Christian, but not Catholic. Three hundred fifteen patients (97%) considered themselves spiritual and 89% religious, with median intensities of 7 (interquartile range [IQR]: 5-10) and 7 (5-9), respectively (0-10 scale, 10 = "very much"). Median importance of spirituality/religiosity was 10 (IQR: 8-10). The frequency and associations between spirituality/religiosity and various items were as follows: helps to cope with illness (98%; r = 0.66303; p < 0.0001), positive effect on physical symptoms (81%; r = 0.42067; p < 0.0001), and emotional symptoms (84%; r = 0.16577; p < 0.0001). One hundred ninety-five patients (60%) reported that their spiritual/religious needs had not been supported by the medical team. Spiritual pain was reported in 162/311 patients (52%), with median intensity of 6 (IQR: 5-8). Spiritual pain was associated with pain (p = 0.0225), depression (p < 0.0001), anxiety (p < 0.0001), worry (p < 0.001), behavioral disengagement (p = 0.0148), FACIT-Sp-Ex score (p = 0.0002), and negative RCOPE (p < 0.0001). Significance of Results: Spirituality and religiosity are frequent, intense, and rarely addressed among Latin American patients. Spirituality/religiosity was associated with positive COPE and higher QOL. Spiritual pain was also frequent and associated with physical and psychosocial distress. These patients need increased spiritual/religious support.

The development of a nomogram to determine the frequency of elevated risk for non-medical opioid use in cancer patients.

OBJECTIVE: Non-medical opioid use (NMOU) is a growing crisis. Cancer patients at elevated risk of NMOU (+risk) are frequently underdiagnosed. The aim of this paper was to develop a nomogram to predict the probability of +risk among cancer patients receiving outpatient supportive care consultation at a comprehensive cancer center. METHOD: 3,588 consecutive patients referred to a supportive care clinic were reviewed. All patients had a diagnosis of cancer and were on opioids for pain. All patients were assessed using the Edmonton Symptom Assessment Scale (ESAS), Screener and Opioid Assessment for Patients with Pain (SOAPP-14), and CAGE-AID (Cut Down-Annoyed-Guilty-Eye Opener) questionnaires. "+risk" was defined as an SOAPP-14 score of ≥7. A nomogram was devised based on the risk factors determined by the multivariate logistic regression model to estimate the probability of +risk. RESULTS: 731/3,588 consults were +risk. +risk was significantly associated with gender, race, marital status, smoking status, depression, anxiety, financial distress, MEDD (morphine equivalent daily dose), and CAGE-AID score. The C-index was 0.8. A nomogram was developed and can be accessed at https://is.gd/soappnomogram. For example, for a male Hispanic patient, married, never smoked, with ESAS scores for depression = 3, anxiety = 3, financial distress = 7, a CAGE score of 0, and an MEDD score of 20, the total score is 9 + 9+0 + 0+6 + 10 + 23 + 0+1 = 58. A nomogram score of 58 indicates the probability of +risk of 0.1. SIGNIFICANCE OF RESULTS: We established a practical nomogram to assess the +risk. The application of a nomogram based on routinely collected clinical data can help clinicians establish patients with +risk and positively impact care planning.

Random urine drug testing among patients receiving opioid therapy for cancer pain.

BACKGROUND: There is limited information regarding the true frequency of nonmedical opioid use (NMOU) among patients receiving opioid therapy for cancer pain. Data to guide patient selection for urine drug testing (UDT) as well as the timing and frequency of ordering UDT are insufficient. This study examined the frequency of abnormal UDT among patients with cancer who underwent random UDT and their characteristics. METHODS: Demographic and clinical information for patients with cancer who underwent random UDT were retrospectively reviewed and compared with a historical cohort that underwent targeted UDT. Random UDT was ordered regardless of a patient's risk potential for NMOU. Targeted UDT was ordered on the basis of a physician's estimation of a patient's risk for NMOU. RESULTS: In all, 552 of 573 eligible patients (96%) underwent random UDT. Among these patients, 130 (24%) had 1 or more abnormal results; 38 of the 88 patients (43%) who underwent targeted UDT had 1 or more abnormal results. When marijuana was excluded, 15% of the random group and 37% of the targeted group had abnormal UDT findings (P < .001). It took a shorter time from the initial consultation to detect 1 or more abnormalities with the random test than the targeted test (median, 130 vs 274 days; P = .02). Abnormal random UDT was independently associated with younger age (P < .0001), male sex (P = .03), Cut Down, Annoyed, Guilty, and Eye Opener-Adapted to Include Drugs positivity (P = .001), and higher Edmonton Symptom Assessment System anxiety (P = .01). CONCLUSIONS: Approximately 1 in 4 patients receiving opioids for cancer pain at a supportive care clinic who underwent random UDT had 1 or more abnormalities. Random UDT detected abnormalities earlier than the targeted test. These findings suggest that random UDT is justified among patients with cancer pain.

Integration of a Mandatory Palliative Care Education Into Hematology-Oncology Fellowship Training in a Comprehensive Cancer Center: A Survey of Hematology Oncology Fellows.

PURPOSE: The primary aim of this study was to determine the attitudes and beliefs of hematology and medical oncology (HMO) fellows regarding palliative care (PC) after they completed a 4-week mandatory PC rotation. METHODS: The PC rotation included a 4-week standardized curriculum covering all PC domains. HMO fellows were provided educational materials and attended all didactic sessions. All had clinical rotation in an acute PC unit and an outpatient clinic. All HMO fellows from 2004 to 2017 were asked to complete a 32-item survey on oncology trainee perception of PC. RESULTS: Of 105 HMO fellows, 77 (73%) completed the survey. HMO fellows reported that PC rotation improved assessment and management of symptoms (98%); opioid prescription (89%), opioid rotation (78%), and identification of opioid adverse effects (87%); communication with patients and families (91%), including advance care planning discussion (88%) and do-not-resuscitate discussion (88%); and they reported comfort with discussing ethical issues (74%). Participants reported improvement in knowledge of symptom assessment and management (n = 76; 98%) as compared with efficacy in ethics (n = 57 [74%]; P = .0001) and for coping with stress of terminal illness (n = 45 [58%]; P = .0001). The PC rotation educational experience was considered either far better or better (53%) or the same (45%) as other oncology rotations. Most respondents (98%) would recommend PC rotations to other HMO fellows, and 95% felt rotation should be mandatory. CONCLUSION: HMO fellows reported PC rotation improved their attitudes and knowledge in all PC domains. PC rotation was considered better than other oncology rotations and should be mandatory.

Patients' Perspective of Timeliness and Usefulness of an Outpatient Supportive Care Referral at a Comprehensive Cancer Center.

CONTEXT: Current guidelines recommend early referral to palliative care for patients with advanced cancer; however, no studies have examined the optimal timing of referral from the patients' perspective. OBJECTIVES: To examine patients' perceptions of timeliness of referral and its association with survival among patients with advanced cancer referred to an outpatient supportive care (SC) clinic. METHODS: This cross-sectional prospective study in an SC clinic at a comprehensive cancer center included patients aged 18 years or older with locally advanced, recurrent, or metastatic cancer. Patients were asked to complete an anonymous survey regarding the timeliness and perceived usefulness of SC referral within four weeks of their first SC consultation. RESULTS: Of 253 eligible patients, 209 (83%) enrolled in the study and 200 completed the survey. Median survival was 10.3 months. Most patients (72%) perceived that referral occurred "just in time," whereas 21% felt it was "late," and 7% felt "early." A majority (83%) found the referral useful, and 88% would recommend it to other patients with cancer. The perception of being referred early was associated with lower reported levels of pain (P = 0.043), fatigue (P = 0.004), drowsiness (P = 0.005), appetite loss (P = 0.041), poor well-being (P = 0.041), and lower physical (P = 0.001) and overall symptom distress (P = 0.001). No other associations were found between perceived timeliness and usefulness and patients' baseline characteristics. CONCLUSION: Most patients with a median survival of 10 months perceived that SC referral was timely and useful. Patient care needs rather than the timing of advanced cancer diagnosis drove this perception of referral timing. Lower symptom burden was associated with the perception of being referred to early.

Characteristics and Outcomes of Psychology Referrals in a Palliative Care Department.

CONTEXT: Psychologists can provide unique contributions to interdisciplinary palliative care. Despite research indicating high distress in palliative care cancer patients, little has been reported regarding the feasibility and practice of psychology in this setting. OBJECTIVES: To review the integration of clinical psychology practice in a palliative care department at a major comprehensive cancer center. METHODS: Retrospective chart review of 1940 unique cancer patients (6451 total patient contacts) referred for psychology services provided by clinical psychologists in palliative care from September 1, 2013 to February 29, 2016. RESULTS: Psychologists provided services to 1644 inpatients (24% of palliative care inpatients) and 296 outpatients (19% of palliative care outpatients). Most of them (85%) received services in the inpatient setting. Most patients were females (57%) and white (68%) with a variety of cancer diagnoses. Adjustment disorders were the most prevalent in both settings with significant differences in other Diagnostic and Statistical Manual of Mental Disorders (5th Edition) diagnoses by service location (P < 0.0001). Psychological assessment (86%) and supportive expressive counseling (79%) were the most frequent services provided in the initial consult. Duration of initial visit was significantly longer in outpatient (median 60 minutes) compared with inpatient setting (median 40 minutes) (P < 0.0001). No significant differences were noted between settings regarding the median number of counseling sessions per patient; however, most (70%) only received one or two sessions. Over time, total patient encounters increased in the inpatient setting (P < 0.0001), whereas session lengths in both settings significantly decreased (P < 0.0001). CONCLUSION: Palliative care psychology services successfully integrated into an interdisciplinary palliative care department and rapidly grew in both inpatient and outpatient settings.

Characteristics of Unscheduled and Scheduled Outpatient Palliative Care Clinic Patients at a Comprehensive Cancer Center.

CONTEXT: There is limited literature regarding outpatient palliative care and factors associated with unscheduled clinic visits. OBJECTIVES: To compare characteristics of patients with unscheduled vs. scheduled outpatient palliative care clinic visits. METHODS: Medical records of 183 unscheduled cancer new outpatients and 104 unscheduled follow-up (FU) patients were compared with random samples of 361 and 314 scheduled new patients and FU patients, respectively. We gathered data on demographics, symptoms, daily opioid usage, and performance status. RESULTS: Compared with scheduled new patients, unscheduled new patients had worse Edmonton Symptom Assessment Scale subscores for pain (P < 0.001), fatigue (P = 0.002), nausea (P = 0.016), depression (P = 0.003), anxiety (P = 0.038), drowsiness (P = 0.002), sleep (P < 0.001), and overall feeling of well-being (P = 0.001); had a higher morphine equivalent daily dose of opioids (median of 45 mg for unscheduled vs. 30 mg for scheduled; P < 0.001); and were more likely to be from outside the greater Houston area (P < 0.001). Most unscheduled and scheduled new and FU visits were for uncontrolled physical symptoms. Unscheduled FU patients, compared with scheduled FU patients, had worse Edmonton Symptom Assessment Scale subscores for pain (P < 0.001), fatigue (P < 0.001), depression (P = 0.002), anxiety (P = 0.004), drowsiness (P = 0.010), appetite (P = 0.023), sleep (P = 0.022), overall feeling of well-being (P < 0.001), and higher morphine equivalent daily dose of opioid (median of 58 mg for unscheduled FU visits vs. 40 mg for scheduled FU visits; P = 0.054). CONCLUSION: Unscheduled new FU patients have higher levels of physical and psychosocial distress and higher opioid intake. Outpatient palliative care centers should consider providing opportunities for walk-in visits for timely management and close monitoring of such patients.

Cranial Electrotherapy Stimulation for the Management of Depression, Anxiety, Sleep Disturbance, and Pain in Patients With Advanced Cancer: A Preliminary Study.

CONTEXT: Cranial electrotherapy stimulation (CES) is a safe modulation of brain activity for treating depression, anxiety, insomnia, and pain. However, there are no published studies in patients with advanced cancer (ACPs). OBJECTIVES: The aim of the study was to determine the feasibility and preliminary efficacy of a four-week CES intervention on depression, anxiety, sleep disturbance, and pain scores. Concurrent salivary biomarker studies were conducted. METHODS: In this one group open label pre- and post-intervention study with a four-week CES intervention, ACPs with one or more of four moderate intensity (≥3/10) Edmonton Symptom Assessment Scale (ESAS) symptoms (depression, anxiety, sleep disturbance, and pain) were eligible. Adherence (0%-100%), satisfaction rates (0-10), and safety were assessed. ESAS, Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index, Brief Pain Inventory, and salivary levels (cortisol, alpha amylase, C-reactive protein, and interleukin-1ß, and interleukin-6) were assessed from baseline to Week 4. RESULTS: Thirty-three of 36 patients (92%) completed the CES. Median (interquartile range) adherence CES use and satisfaction scores were 93% (89-100) and 10% (9-10), respectively, and the adherence criteria was met in the study. CES use was safe (no Grade 3 or higher adverse events). HADS anxiety (P < 0.001), HADS depression (P = 0.024), ESAS anxiety (P = 0.001), ESAS depression (P = 0.025), Brief Pain Inventory pain (P = 0.013), Pittsburgh Sleep Quality Index daytime dysfunction (P = 0.002), and medication use (P = 0.006) scores improved after four-week CES treatment. CONCLUSION: In this preliminary study, we found that the use of CES was safe and feasible in ACP. The use of CES was associated with significant improvement of depression, anxiety, pain, and sleep scores. These findings support further studies of CES in ACP for symptom control.

Timing of Referral and Characteristics of Uninsured, Medicaid, and Insured Patients Referred to the Outpatient Supportive Care Center at a Comprehensive Cancer Center.

CONTEXT: Low-income patients face barriers to palliative care access, which might negatively influence symptom management and advanced care planning. OBJECTIVE: Our aim was to compare time of referral and characteristics (level of symptom distress) among uninsured (indigent), low-insured (Medicaid), and insured patients presenting to our supportive care center (SCC). METHODS: We conducted a retrospective review of randomly selected 100 indigent, 100 Medicaid, and 300 insured outpatients referred during the same five-year period. We reviewed demographic and clinical characteristics including date of diagnosis of advanced cancer and of first visit to SCC, symptom assessment (Edmonton Symptom Assessment System), type and dose of opioid medication, number of total outpatient visits, and date of last contact with palliative care team. RESULTS: Among 482 evaluable patients, indigent, Medicaid, and insured patients, respectively, had mean (SD) ages of 48 (11), 50 (12), and 63 (13) years (P < 0.001); Edmonton Symptom Assessment System pain scores at first visit of 6.7 (2.5), 5.6 (3.2), and 4.9 (3.2) (P < 0.001); nonwhite race in 60%, 49%, and 25% of cases (P < 0.001); unmarried status in 68%, 64%, and 33% of cases (P < 0.001), while 63%, 87%, and 54% of patients (P < 0.001) were on opioids with median number of encounters per month of 0.6, 0.8, and 0.5 (P = 0.001). Median survival (95% CI) from first visit to last contact was 4.6 (2.8-6.2), 5.4 (3.5-7), and 5.6 (4.7-7.3) months (P = 0.036). CONCLUSION: Patients with limited or no insurance had significantly higher pain and were more frequently on opioids, younger, nonwhite, and not married. They required higher number of SCC follow-up visits. Insurance status did not affect timing of SCC referral or follow-ups at our cancer center.

Frequency of venous thromboembolism events during acute inpatient rehabilitation in a comprehensive cancer centre.

OBJECTIVE: To determine the frequency of venous thromboembolism, possible predictors, and the association between venous thromboembolism and Functional Independence Measure (FIM) scores and length of stay among cancer patients admitted to the inpatient rehabilitation unit at a cancer centre. DESIGN: Retrospective analysis of patients admitted to acute inpatient rehabilitation from September 2011 to June 2013. Subject/patients: Cancer patients in the acute inpatient rehabilitation unit within a tertiary cancer centre. METHODS: International Classification of Diseases (ICD-9) codes identified deep vein thrombosis, pulmonary embolism, and inferior vena cava filter. RESULTS: Venous thromboembolism occurred in 32/611 patients (5.2%): 23/611 (3.8%) during the course of hospitalization before admission to rehabilitation, and 9/611 patients (1.5%) during rehabilitation. Patients with lower extremity oedema at admission (p = 0.0218) had a higher chance of subsequently developing venous thromboembolism. Patients with venous thromboembolism during rehabilitation had a significantly lower FIM transfer score at admission to rehabilitation (p = 0.0247), a longer length of stay in rehabilitation (p = 0.0013) and overall hospitalization (p = 0.0580). CONCLUSION: Cancer patients with low FIM transfer scores and lower extremity oedema are at higher risk of venous thromboembolism. Patients with these clinical findings at admission may require measures for more aggressive surveillance for the presence of venous thromboembolism. Patients with venous thromboembolism had an increased length of stay in rehabilitation, but ultimately did not have significant differences in FIM score changes.

Phase Ib Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Patients with Barrett's Esophagus.

This study was conducted to determine the safety and efficacy of the green tea-derived Polyphenon E (Poly E) in patients with Barrett's Esophagus (BE). Subjects were randomized to a 6-month, twice daily (BID) oral treatment of placebo or Poly E (200, 400, or 600 mg). Endoscopic evaluation, including biopsies, was performed before and after treatment. The primary objective was to demonstrate safety; secondary objectives investigated catechin accumulation and effects in clinical specimens. Of the 44 enrolled subjects, 11 received placebo, and 33 received Poly E. No dose-limiting toxicities were encountered, and a maximum tolerated dose (MTD) was not reached. The recommended phase II dose was 600 mg twice daily. The most common treatment-related adverse events (AE) in Poly E-treated subjects were grade I and II nausea, grade I belching, and grade I lactate dehydrogenase (LDH) elevation. No treatment-related AEs were reported in placebo-treated subjects, aside from grade I laboratory abnormalities. Pill counts and subject diaries were not consistently collected, and compliance was difficult to determine. However, on the basis of an intention-to-treat analysis, there was a significant relationship between Poly E dose and esophageal EGCG level--mean changes (pmol/g) of 0.79 (placebo), 6.06 (200 mg), 35.67 (400 mg), and 34.95 (600 mg); P = 0.005. There was a possible relationship between Poly E dose and urine PGE-M concentration. In conclusion, Poly E was well-tolerated, and treatment with Poly E (400 and 600 mg) but not Poly E (200 mg) or placebo resulted in clinically relevant and detectable EGCG accumulation in the target organ, esophageal mucosa.

The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma: potential for decreased toxicity and combination with biological therapy.

BACKGROUND: Gemcitabine and vinorelbine are two of the most active third-generation agents for the treatment of advanced nonsmall cell lung carcinoma (NSCLC). The authors conducted a formal Phase II trial to evaluate the efficacy of this combination in both untreated and previously treated patients with Stage IIIB (with pleural effusion) or Stage IV NSCLC. METHODS: A total of 78 patients were treated on the current Phase II trial of front-line or second/third-line therapy with gemcitabine and vinorelbine in NSCLC. Eligible patients manifested either untreated disease (n = 42) or had received at least one but not more than two prior chemotherapy regimens (n = 36). The median age was 57.5 years (range, 33-79) with 57 men (73%) and 21 women (27%). The median performance status was one (range, one to two). The initial eight patients (four untreated and four previously treated) were treated at a previously established maximum tolerated dose of vinorelbine (30 mg/m(2)) and gemcitabine (1000 mg/m(2)) on Days 1, 8, and 15, with significant myelosuppression seen in five out of eight patients requiring dose omission in the first cycle. The next 70 patients received a reduced dose of vinorelbine (25 mg/m(2)) followed by gemcitabine (900 mg/m(2)) on Days 1, 8, and 15. RESULTS: Seventy eight patients were treated. Fifteen (36%) of the 42 evaluable patients who received front-line therapy had objective responses and 14 (33%) had stable disease. In the patients with prior treatment, 6 (17%) of 36 patients had partial response and 18 patients (50%) had stable disease. Median survival time for the previously untreated patient group was 10.1 months, with a one year survival of 43% and a two year survival rate of 32%. For the previously treated patients, the median survival time was 8.5 months, with a one year survival rate of 30%. Toxic effects were notable for significant myelosuppression, with > or =Grade 3 granulocytopenia seen in 55% of the patients on the untreated arm and 67% of the patients on the previously treated arm. Additionally, 9.5% and 13.9% (untreated and previously treated), respectively, of these patients experienced Grades 3 and 4 thrombocytopenia at some point in their treatment. A full dose delivery analysis showed that this myelosuppression resulted in Course 1, Day 15 skipped doses (even at the reduced dose level) in 42% of previously untreated patients and 47% of pretreated patients. Other side effects seen at Grades 3 and 4 in previously untreated and treated patients included anemia (9.5% and 2.8%), asthenia (4.8% and 5.5%), infection (14.3% and 5.6%), pain (9.5% and 19.4%), and pulmonary complications (4.8% and 13.8%). CONCLUSIONS: Gemcitabine/vinorelbine is an active, well-tolerated combination in both front-line and second/third-line therapy for Stage IIIB/IV NSCLC. The response rate, median survival rate, and one year survival rate compare favorably with platinum-based regimens. The toxicity profile of the gemcitabine/vinorelbine combination was quite favorable, with minimal Grade 3 and 4 toxic effects aside from granulocytopenia, which resulted in numerous Day 15 skipped doses but no significant febrile neutropenia or infection. The combination of gemcitabine and vinorelbine could be a useful regimen in standard clinical practice and has the potential for efficient combination with biologic/targeted therapy. Multiple randomized trials of this combination versus platinum combinations are now ongoing [corrected].