Non‐chronic lymphocytic leukemia (non‐CLL) clonal B‐cell lymphocytosis (CBL) encompasses a heterogeneous group of hematologic disorders that are still poorly understood. To shed light on their ...biological aspects, we retrospectively analyzed a highly selected series of 28 patients, who had a clonal B‐cell population in the peripheral blood and in the bone marrow, without evidence of lymphoma. Extended targeted next‐generation sequencing revealed wide molecular heterogeneity with MYD88 (14%), PDE4DIP (14%), BIRC3 (11%), CCND3 (11%), NOTCH1 (11%), and TNFAIP3 (11%) as the most mutated genes. Mutations of MYD88 were “nonclassic” in most cases. Although some genetic lesions were overlapping with indolent lymphomas, mainly splenic B‐cell lymphomas of marginal zone origin and splenic diffuse red pulp small B‐cell lymphoma, the genetic profile of our non‐CLL CBL series seemed to suggest that various pathways could be involved in the pathogenesis of these disorders, not mirroring any specific lymphoma entity. These data better enlighten the molecular characteristics of non‐CLL CBL; however, more efforts are needed in order to improve the diagnostic process, prognostication, and clinical management.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
Background: Marginal zone Lymphomas (MZL) are indolent B cell non hodgkin Lymphoma (NHL) and include splenic, nodal and extranodal subtypes (SMZL, NMZL, ENMZL). When therapy is needed in symptomatic ...patients, standard treatment usually requires systemic immunochemotherapy (ICT). Although the outcome of MZL is generally measured in decades a high heterogeneity of clinical behaviour exists that warrants the identification of accurate prognostic features to better estimate the risk of relapse, progression or death in the individual patient. Recently the analysis of progression free survival (PFS) was used to identify clinically useful endpoints in B-cell NHLs, with PFS at 24 (PFS24) months identified to stratify overall survival (OS) in follicular NHL. Here we examined the ability of PFS24 to predict subsequent OS in a large, multinational MZL cohort as part of the NF10 observational multicentric international study promoted by Fondazione Italiana Linfomi (FIL).
Methods: The NF10 Project was started in 2010 as a prospective registry specifically conceived to investigate the prognosis of Indolent Non-Follicular B-Cell Lymphomas (INFL). The registration of clinical, laboratory data, treatment and outcome details of consecutive adult patients with newly diagnosed INFL was available at a dedicated website. All patients with a histologic confirmed diagnosis of INFL also including MZL were eligible with no exclusion criteria. Patients were followed based on local institution guidelines, and PFS was defined as time from the date of pathologic diagnosis to progression, re-treatment, or death due to any cause. PFS24 was calculated only for patients requiring immediate therapy and was defined as being alive and progression-free 24 months from diagnosis. Subsequent OS was defined as time from achieving PFS24 or time from progression in patients failing to achieve PFS24 (progression within 24 months of diagnosis).
Results: Between July 2010 and July 2018, 1.253 INFL cases have been registered by 65 centres in Europe and South America. MZLs were 677 (54%): 283 ENMZL (43%), 221 SMZL (32%), 69 NMZL (10%); 104 cases were classified as disseminated MZL (Diss-MZL 15%) due to the lack of a clear pattern of organ involvement. Median age was 66 years (range 27-93); Ann Arbor stage was III-IV in 79%; 14% had B symptoms, 6% had ECOG performance status (PS) >1, lactate dehydrogenase (LDH) and β2-microglobulin were above upper normal limit (UNL) in 26% and 56% of cases respectively. Bone marrow involvement was present in 67%, positive HCV and HBV serology was found in 8% and 18% of cases respectively.
For the current study we identified 400 patients with MZL for whom immediate therapy was planned right after lymphoma diagnosis. Patients with immediate therapy were 59% of all MZL. Rituximab (R) combined with chemotherapy was used in 332 (82%): R plus bendamustine (RB) in 142 (36%), R plus alkylating agents (R-alk) in 101 cases (25%) (mostly ENMZL), R plus CHOP in 50 (12%) (mainly NMZL and DissMZL); R monotherapy was used in 36 (9%).
The median follow-up was 38 months (range 1-83). For treated pts 3y-PFS was 79% and 3y-OS was 90%; progressive disease was the cause of death in 47% of all cases.
The percentage of patients who failed to achieve PFS24 was 20% with a lower frequency in the subtypes NMZL and ENMZL (13%) compared to the group of SMZL and DissMZL (24%, p=0.015). Three-year OS for patients with progression within the first 24 months was 46% (95%CI 28-63%) with a HR of 28.3 (95%CI 10.6 - 75.6) when compared with patients without early relapse (96%, 95%CI 91-98%). When PFS24 was adjusted by IPI in all cases and by HPLL (Montalbán et al, BJH 2012) in SMZL, the PFS24 retained its prognostic role (p<0.001).
The prognostic role of PFS24 was confirmed in ENMZL, SMZL and Diss-MZL subgroups (Figure 1). At present, in NMZL there were too few events to do an inference. At univariate logistic analysis predictive factors for PFS24 were the subtypes group SMZL/Diss MZL, poor ECOG PS, hemoglobin <9.5g/dl, BM involvement, platelets counts < 80.000/mmc, low albumin.
Conclusions: Assessment of PFS24 predicts subsequent outcome in MZL. The prognostic role of PFS is confirmed in both ENMZL and SMZL. Similarly to FL also in MZL, PFS24 should be considered as a surrogate for OS in clinical research and for patients management.
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Luminari:Servier: Consultancy; Gilead: Consultancy; Celgene: Consultancy; Roche: Consultancy; Sandoz: Consultancy. Marcheselli:Fondazione Italiana Linfomi (FIL) Onlus: Employment. Annibali:Celgene; Takeda; Amgen, Janssen Cilag: Honoraria. Gaidano:Morphosys: Honoraria; AbbVie: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Roche: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Gilead: Consultancy, Honoraria.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Chronic hepatitis C virus (HCV) infection is related with an increased risk of non‐Hodgkin lymphomas (NHL). In indolent subtypes, regression of NHL was reported after HCV eradication with antiviral ...therapy (AT). In 2008 in Lombardy, a region of Northern Italy, the “Rete Ematologica Lombarda” (REL, Hematology Network of Lombardy—Lymphoma Workgroup) started a prospective multicenter observational cohort study on NHL associated with HCV infection, named “Registro Lombardo dei Linfomi HCV‐positivi” (“Lombardy Registry of HCV‐associated non‐Hodgkin lymphomas”). Two hundred fifty patients with a first diagnosis of NHL associated with HCV infection were enrolled; also in our cohort, diffuse large B cell lymphoma (DLBCL) and marginal zone lymphoma (MZL) are the two most frequent HCV‐associated lymphomas. Two thirds of patients had HCV‐positivity detection before NHL; overall, NHL was diagnosed after a median time of 11 years since HCV survey. Our data on eradication of HCV infection were collected prior the recent introduction of the direct‐acting antivirals (DAAs) therapy. Sixteen patients with indolent NHL treated with interferon‐based AT as first line anti‐lymphoma therapy, because of the absence of criteria for an immediate conventional treatment for lymphoma, had an overall response rate of 90%. After a median follow‐up of 7 years, the overall survival (OS) was significantly longer in indolent NHL treated with AT as first line (P = 0.048); this confirms a favorable outcome in this subset. Liver toxicity was an important adverse event after a conventional treatment in 20% of all patients, in particular among DLBCL, in which it is more frequent the coexistence of a more advanced liver disease. Overall, HCV infection should be consider as an important co‐pathology in the treatment of lymphomas and an interdisciplinary approach should be always considered, in particular to evaluate the presence of fibrosis or necroinflammatory liver disease.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
Background: Marginal Zone Lymphomas (MZLs) are low-grade B cell lymphomas which include extranodal MZL (EMZL) of the mucosa-associated lymphoid tissue (MALT), splenic MZL (SMZL), nodal MZL (NMZL). No ...definite consensus exists on treatment of MZL and although MZL generally shows an indolent course, high risk patients (pts), if early identified, might be intensively treated.
Aim of the study: The NF10 Project was started in 2010 by the Fondazione Italiana Linfomi as a prospective registry specifically conceived to investigate the prognosis of Indolent Non-Follicular B-Cell Lymphomas (INFL).We present an analysis of the registered MZLs, focusing on clinical aspects, pattern of care and outcome.
Methods: The registration of clinical, laboratory data along with treatment and outcome details of consecutive adult pts with newly diagnosed INFL is active at a dedicated website. All pts with a histologic confirmed diagnosis of INFL, including MZL, were eligible with no exclusion criteria. So far, the study has been activated in 65 centres in Europe and South America.
Results: Between July 2010 and July 2017, 1.044 INFL cases have been registered. MZLs were 549 (53%): 216 EMZL (39%), 185 SMZL (34%), 50 NMZL (9%); 98 cases were registered and classified as MZL Not Otherwise Specified (NOS 18%) based on the lack of a clear pattern of organ involvement. Median age was 66 years (range 27-93); Ann Arbor stage was III-IV in 75%; 15% had B symptoms, 6% had ECOG performance status (PS) >1, lactate dehydrogenase (LDH) and β2-microglobulin were > upper normal limit (UNL) in 29% and 49% of cases respectively; 9% had positive HCV serology and 20% positive HBV serology (17% HBcAb-positive and 3% HBsAg-positive). Bone marrow involvement was present in 58%; upper gastrointestinal site was involved in 55 EMZLs (27%). More than one extranodal sites (ENS>1) were involved in 37 cases (7%) (Table 1).
Regarding treatment, we observed a high heterogeneity in the treatment modalities across MZL subtypes and among pts subtypes within each MZL group. Immediate systemic treatment was planned in 324 pts (60%); in 149 pts addressed to observation, the median time to treatment (months) was 26.2 for MZL NOS, 15.5 for SMZL, 14.2 for NMZL and 5.1 for EMZL. The subtypes with the higher rates of immediate systemic therapy were EMZL, MZL NOS and NMZL (70%, 61%, 60% respectively). Bone marrow involvement (p<0.001), increased β2-microglobulin (p=0.006), ENS>1 (p=0.001) and HBV infection (p=0.009) were factors significantly associated with the need of immediate systemic treatment.
Rituximab (R) combined with chemotherapy was used in 248 (76%): R plus bendamustine (RB) in 114 (35%), R plus alkylating agents (R-alk) in 86 cases (27%) (mostly EMZL), R plus CHOP in 45 (14%) (mainly NMZL and MZL NOS); R monotherapy was used in 29 (9%). Since 2010 the use of RB has been increased from 9% to 40%. Conversely, the use of alkylating agents and/or CHOP decreased from 70% to 20%.
The median follow-up was 32 months (range 1-80). For treated pts 3y-PFS was 80% and 3y-OS was 89%; progressive disease was the cause of death in 33% of all cases. Overall, no difference was observed between RB and R-alk in terms of overall response rate (ORR), 3-year progression-free survival (3y-PFS), 3-year overall survival (3y-OS) and 3-year Failure-Free Survival (3y-FFS).
Among MZLs, IPI was able to identify a subgroup of 115 pts (24%) at high risk that showed a significantly shorter PFS and OS compared to intermediate and low risk subjects. Using subtype specific scores the HPLL (Montalbán et al, BJH 2012) for SMZL was able to identify 9 high risk pts (5%) with a 3y-PFS and 3y-OS of 35% and 48%, respectively. The recently published score for ENMZL generated from the dataset of the IELSG-19 clinical trial (Thieblemont et al, Blood 2017), was also considered for EMZL cases and was able to identify 29 (16%) high risk pts with a 3y-PFS and 3y-OS of 75% and 87%, respectively.
Conclusions: We provide an analysis of initial characteristics, treatment and outcome of a large series of pts with MZL. Despite the indolent course of MZL, a minority of pts with more aggressive clinical course is seen. Currently available scores suffer from a limited ability to identify a significant proportion of high risk pts who might be eligible to more intensive therapies. The NF10 Project with its relevant data collection deriving from a world-wide cooperation provides a solid base for future prognostic analysis and biological studies.
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Re:Gilead: Membership on an entity's Board of Directors or advisory committees. Gaidano:Janssen: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria; Roche: Consultancy, Honoraria; Amgen: Consultancy, Honoraria. Luminari:TAKEDA: Membership on an entity's Board of Directors or advisory committees; TEVA: Membership on an entity's Board of Directors or advisory committees; GILEAD: Speakers Bureau; PFIZER: Speakers Bureau; CELGENE: Honoraria, Membership on an entity's Board of Directors or advisory committees; ROCHE: Membership on an entity's Board of Directors or advisory committees. Arcaini:Pfizer: Membership on an entity's Board of Directors or advisory committees; Sandoz: Consultancy; Gilead: Research Funding; Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bayer: Membership on an entity's Board of Directors or advisory committees.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Introduction. The majority of SMZLs display an indolent course, however the disease is still incurable and a significant proportion of patients (~25-30%) experience poor outcomes surviving <5 years. ...Molecular alterations of SMZL are promising biomarkers, which might improve risk stratification of patients. The main objective of the study is to test the impact of molecular aspects on disease-specific survival prognostication in newly diagnosed SMZL. Methods. IELSG46 is a multicenter, international, retrospective, observational study in which already existing and coded health-related personal and biological material is used. The study included adults, who received a diagnosis of SMZL on spleen histology with a follow up >5 years, and for whom tumor material collected before initiation of medical therapy was available. Mutation analysis was performed by CAPP-seq targeted deep next generation sequencing of tumor genomic DNA. A stringent bioinformatic pipeline was applied to suppress the background noise allowing to call variants with a sensitivity of 5x10-2 in FFPE derived DNA. Copy number variations (CNVs) were identified by using the sequencing reads-based GATK4-CNV algorithm. IGHV rearrangements were obtained by using LymphoTrack® IGH FR1 Assay Panel kit. Molecular clusters were identified by an iterative algorithm that maximizes genetic distinctiveness of subgroups by reassigning patients between clusters that are created a priori based on the co-occurrence of genetic lesions. Relative survival, defined as the ratio between actuarial survival observed in the SMZL cohort and expected survival of the general population matched to patients by geographical origin, sex, age and calendar year of diagnosis, was calculated using the Ederer II method. Results. The analysis included 303 patients with a SMZL diagnosis confirmed on spleen histology. The sample size allowed to identify 30% differences in survival for molecular subgroups comprising at least 5% of cases with a statistical power between 80-100%. Median follow-up was 9.2 years. At 10 years, 85% of patients were alive, consistent with the known indolent behavior of this lymphoma. Genes recurrently affected by non-synonymous somatic mutations in >10% of SMZL included KLF2 (24%), NOTCH2 (19%), KMT2D (15%), TNFAIP3 (13%), EP300 and TP53 (10%). Deletion 7q was documented in 25% of cases and IGHV1-2*04 usage in 32%. By cluster analysis, three major molecular subgroups were identified, each of them characterized by a NOTCH pathway mutated gene (Fig. 1A). The first cluster was defined by NOTCH2 and/or KLF2 mutations and was enriched in TNFAIP3 mutations and IGHV1-2*04 gene usage (Fig. 1A). The second cluster was defined by SPEN mutations, and was enriched in KMT2D and other epigenetic gene mutations (Fig. 1A). The third cluster was enriched in NOTCH1 mutations (Fig. 1A). By relative survival analysis, the NOTCH2/KLF2 cluster showed a lower survival compared to the matched general population, indicating a significant impact of the disease on patients' expected survival (Fig. 1B). Conclusions. The large sample size and inclusion of SMZL confirmed by spleen histopathology review allowed for precise estimation of the prevalence of KLF2 and NOTCH2 mutations in this lymphoma. Three molecular clusters were identified in SMZL, each of them containing a NOTCH pathway gene, supporting the relevance of NOTCH signaling in the pathogenesis of SMZL. Patients belonging to the NOTCH2/KLF2 cluster had a lower relative survival compared to the matched general population.
Traverse-Glehen:Astra Zeneca: Other: Travel; Takeda: Research Funding. Gomes da Silva:Roche: Other: Institution's payment for consultancy, Travelling support; BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: lecture fees; Celgene: Other: Travelling support; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: lecture fees, Institution's payment for consultancy, Travelling support; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: lecture fees; Gilead Sciences: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: lecture fees, Research Funding. Ladetto:Celgene: Honoraria; Jannsen: Honoraria; Acerta: Honoraria; Abbvie: Honoraria; Sandoz: Honoraria; Roche: Honoraria. Rambaldi:Pfizer: Consultancy; Novartis: Consultancy; Omeros: Consultancy; Italfarmaco: Consultancy; Amgen Inc.: Consultancy; Roche: Consultancy; Celgene: Consultancy. Vitolo:Takeda: Speakers Bureau; Sandoz: Speakers Bureau; Gilead: Speakers Bureau; Janssen: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Roche: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Zinzani:MSD: Honoraria, Speakers Bureau; Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; SERVIER: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; TG Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bayer: Membership on an entity's Board of Directors or advisory committees; PFIZER: Honoraria, Membership on an entity's Board of Directors or advisory committees; Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Speakers Bureau; Bayer: Membership on an entity's Board of Directors or advisory committees; TG Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celltrion: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Membership on an entity's Board of Directors or advisory committees; PFIZER: Honoraria, Membership on an entity's Board of Directors or advisory committees; Verastem: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees; Astra Zeneca: Speakers Bureau. Gaidano:Roche: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria; Morphosys: Honoraria; Amgen: Consultancy, Honoraria; Janssen: Consultancy, Honoraria. Salles:Servier: Honoraria; Abbvie: Honoraria; F. Hoffmann-La Roche Ltd: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria; Amgen: Honoraria; BMS: Honoraria, Other: Advisory Board; Celgene: Honoraria, Other: Advisory Board, Research Funding; Acerta: Honoraria; Janssen: Honoraria, Other: Advisory Board; Merck: Honoraria; Pfizer: Honoraria; Morphosys: Honoraria; Gilead: Honoraria, Other: Advisory Board; Epizyme: Honoraria; Servier: Honoraria, Other: Advisory Board; Takeda: Honoraria. Zucca:Celltrion: Consultancy; AstraZeneca: Consultancy.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Introduction: Transformation of Marginal Zone Lymphoma (MZL) into an aggressive histology is uncommon phenomenon that can occur at any time after diagnosis and is expected to have a detrimental ...impact on prognosis. Biological and clinical knowledge on transformed Marginal Zone Lymphoma (tMZL) is poor and no standard treatment is established in the Rituximab era for these patients (pts). We retrospectively analyzed all consecutive biopsy proven tMZL in two Italian Hematological Divisions from 2002 to 2014 and we focused on post-transformation treatment and outcome.
Methods: The dataset included 378 MZL pts diagnosed between 2002 and 2014 at Division of Hematology in Pavia and in Milan (Niguarda Hospital): 204 pts (53.9%) by extranodal MALT lymphomas, 113 pts (29.8%) by splenic MZL, and 61 pts (16.3%) by nodal MZL. Histological transformation (HT) was defined as transformation into an aggressive lymphoma at any time from previous MZL diagnosis; only cases with biopsy confirmed HT were comprised in the present analysis, while cases with only clinical suspicion of transformation were not counted as tMZL.
Results: HT was documented in 18 of the 378 pts (4.8%), 6.5% in nodal MZL, 7.0% in splenic MZL and 2.9% in MALT. Histology at transformation was Diffuse Large B-Cell lymphoma in all but one case; the remaining pt was diagnosed as high-grade B-cell lymphoma, unclassifiable. CD20 was negative only in one Rituximab-naïve pt. Median time from first diagnosis to HT was 31 months (range: 10-124) and median number of previous therapies was 1 (range 0-1); pts received first line therapy listed in table 1.
Median age at transformation was 68 years (range: 46-85), M/F ratio was 0.8. In the tMZL population, first diagnosis was nodal MZL in 4 pts (22%), splenic MZL in 8 pts (45%) and MALT in 6 pts (33%). At first diagnosis of MZL, 72% of t-MZL pts had stage IV disease, 17% had B symptoms, 11% had elevated LDH and ECOG performance status was lower than 2 in all the cases. HCV serology was positive in 5/17 cases; HCV status was not available for one pt. At HT disease stage was III or IV in 14 pts (78%), B symptoms were present in 7 pts (39%), LDH and beta2microglobulin were both elevated in 7 pts (39%) and ECOG performance status was lower than 2 in all the cases. Pts received post-HT treatment listed in table 2.
At time of analysis 6 pts died (33%), and the main cause of death was progressive disease. With a median post-transformation follow-up of 16.6 months (range: 2-98), the 2-years Progression-Free Survival (PFS) was 45,4 % and the 2-years Overall Survival (OS) was 56.75%. No correlation was found between the following characteristics and survival: MZL type at first diagnosis, stage, symptoms, LDH and ECOG at HT, number and types of pre-HT therapies.
Conclusions: This large cohort confirms that HT is a relatively rare and early event in MZL. At present time, we did not identify any feature predictive of outcome for transformed MZL. Chemotherapy in combination with Rituximab showed to be an effective treatment for tMZL.
Table 1First line treatmentN. of patients%Therapy strategyCVP739Anthracycline-containing regimen211Chlorambucil monotherapy528Splenectomy15.5H.pylori eradication15.5Watch and wait strategy211Rituximab incorporationIncluded in first line therapy633Maintenance00ResponseORR (%)67CRR (%)33
Table 2Post-HT treatmentN. of patients%Therapy strategyCHOP regimen1689Platinum-containing regimen15.5Missing15.5Rituximab incorporationIncluded in first line therapy1794Maintenance00ASCT consolidation317ResponseORR (%)61CRR (%)59
Rusconi:Roche: Honoraria.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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